PREFACE

Government of India, Ministry of Health and Family Welfare has published a Gazette Notification GSR no. 604 (E) dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules, thereby introducing a new provision for the registration of the manufacturing premises of foreign drug manufacturer and the individual drugs prior to their import into the country. The notification has also introduced few other provisions viz. enhanced import licence fees, increased validity period of licence, deletion of exemption from requirement of import licence for bulk drugs for actual users, requirement of minimum 60% of retained shelf life for imported drugs and provisions for import of small quantities of new drugs by Govt. hospitals for treatment of their own patients etc.

Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. The applications can be made by authorized agents of foreign firms in India. The documents required for registration certificates have been clearly specified in the amendments. The validity of registration certificates will be 3 years from the date on which these are issued. A fee of 1500 USD is to be charged for the registration of overseas manufacturer's premises and fee of 1000 USD will be charged for every individual drug. The rules provide now for inspection of the premises of a foreign manufacturer by Indian Drug Authorities, whenever so required. In such cases, an additional fee of 5000 USD is to be charged. The rules also provided for payment of testing charges by registration holders. The foreign manufacturer or his authorised agent in India shall be liable to report any change in the manufacturing and testing process of a drug. However, no registration certificate shall be insisted in respect of an inactive bulk substance to be used as pharmaceutical aid for manufacture of drug formulation. The registration may be suspended or cancelled in the event any violation of the conditions for registration comes to notice. The new registration and import licence scheme shall also cover diagnostic kits viz. HIV I & II, HBsAg, HCV and blood group reagents.

According to new rules, import licence will be required for all types of drugs instead of existing import licence requirements for Schedule C & C (1) and Schedule X drugs only. Import licence in Form 10 would be granted after completing the registration of overseas manufacturers and their specific drugs to be imported. The import licence for specific drugs will be valid for 3 years from the date on which these are granted. The import licence fee has been kept Rs. 1000/- for a single drug and at the rate of Rs.100/- for additional drug. The fee of import licences for test and analysis of a drug has been kept Rs. 100/- for a single drug and at the rate of Rs. 50/- for each additional drug. The exemption from import licences for the import of bulk drugs by the formulations for actual use under Schedule D has been deleted. A provision has been made that only drugs with minimum 60% of retained shelf life shall be allowed to be imported in the country.

A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their owm patients. The fee for such import licences has been kept Rs. 100/- for a single drug and the rate of Rs. 50/- for each additional drug.

The notification will come into operation with effect from 1st January 2003. In order to enable a smooth change over the new import requirements, it is proposed that all manufacturers/importers who are to obtain registration certificates for drugs, and import licences in January 2003, should submit their applications for registration certificates on or before 31.3.2002 and import licence applications not later than 30.9.2002, thereby giving minimum lead time to process their applications. Existing import of drugs under Form 10 licences will continue up to 31.12.2002. Since the existing validity of Form 10 Licences extends upto the end of next calendar year, it will be stipulated in Form 10 Licences issued w.e.f. 1.1.2002 that validity of such licences will terminate automatically on 31.12.2002.

The new scheme would take care of a long felt need for laying down import registration requirements similar to those adopted by various other countries.

The text of the notification can also be accessed from the website of the Ministry of Health & Family Welfare at the address file:///M|/websites_upto_23Jan03/CDSCO_V6Jan03/html/http//www.mohfw.nic.in

This compilation includes, Chapter III of the Drugs & Cosmetics Act, 1940; Part IV of the Drugs & Cosmetics Rules, 1945 amended upto 24th August 2001; Related circulars issued to various agencies from time to time.

8. Standards of quality - 4[(1) For the purpose of this Chapter, the expression "standard quality" means-
(a) in relation to a drug, that the drug complies with the standard set out in 5[the Second Schedule], and

(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]

(2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or otherwise amend 5[the Schedule], for the purposes of this Chapter, and thereupon 5[the Second Schedule] shall be deemed to be amended accordingly.

6[9. Misbranded drugs - For the purpose of this Chapter, a drug shall deemed to be misbranded-
(a) if it is so coloured, coated, powered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is, or

(b) if it is not labeled in the prescribed manner; or

(c) if its label or container or anything accompanying the drugs bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.]

1[9A. Adulterated drugs - For the purpose of this Chapter, a drug shall deemed to be adulterated, -
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only or a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) If any substance has been mixed therewith so as to reduce its quality or strength.

(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is truly a product.

9D. Spurious cosmetics - For the purpose of this Chapter, a cosmetic shall be deemed to be spurious -
(a) if it is imported under a name which belongs to another cosmetic; or

(b) if it is an intimation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon its label or container the name of other cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity wit such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]

10. Prohibition of import of certain drugs or cosmetics - From such 1date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import-
(a) any drug 2[or cosmetic] which is not of standard quality;

3[(b) any misbranded drug or misbranded 4[or spurious] cosmetic;]

5[(bb) any adulterated 4[or spurious] drugs;]

(c) any drug 2[cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;

6[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container and thereof the true formula or list of 6[active ingredients contained in it together with the quantities thereof];]

(e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;

1[ (ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;]

(f) any drug 1[ or cosmetic] the import of which is prohibited by rule made under this Chapter.

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or for personal use. Provided further that the Central Government may, after consultation with the Board, by notification in the official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality.

Explanation----- 2[***] Omitted.

3[10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest - Without prejudice to any other provision contains in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]

11. Application of law relating to sea customs and powers of Customs Officers-(1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878 (18 of 1978)4 shall, subject to the provisions of Section 13 of this Act, apply in respect of drugs and 5[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under this Act to perform the duties imposed thereby on a 6[Commissioner of Customs] and other officers of Customs, shall have the same powers in respect of such drugs 5[and cosmetics] as they have for the time being in respect of such goods as aforesaid.

7[(2) Without prejudice to the provisions of sub-section (1), the 6[Commissioner of Customs] or any officer of the Government authorized by the Central Government in his behalf, may detain any imported package which he suspects to contain any drug 5[or cosmetic] the import of which is prohibited under this Chapter and shall forthwith report such detection to the Drugs Controller, India and if necessary, forward the package or sample of any suspected drug 5[or cosmetic] found therein to the Central Drug Laboratories.

12. Power of Central Government to make rules - (1) The Central Government may, after consultation with 1[or on the recommendation of] the Board and after previous publication by notification in the Official Gazette, makes rules for the purpose of giving effects to the provisions of this Chapter.

2[Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]

(2) Without prejudice to the generality of the foregoing power, such rules may-

(a) specify the drugs or class of drugs 3[or cosmetics or classes of cosmetics] for import of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefor 4[and provide for the cancellation, or suspension of such licence in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which the licence is issued is not complied with;]

(b) prescribe the methods of test or analysis to be employed in determining whether a drug 5[or cosmetic] is of standard quality;

(c) prescribe in respect of biological and organometallic compounds, the units or methods of standardization; 5[(cc) prescribe under clause (d) of 6[Section 9A] the colour or colours which a drug may bear or contain for purposes of colourings;]

(d) specify the diseases or ailments which an imported drug may not purport or claim 7[to prevent, cure or mitigate] and such other effects which such drug may not purport or claim to have;

(e) prescribe the conditions subject to which small quantities of drugs, the import of which otherwise prohibited under this Chapter, may be imported for the purpose of examination, test or analysis or for personal use;

(f) prescribe the places at which drugs 5[or cosmetics] may be imported, and prohibit their import at any other places;

(g) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified imported drug or class of such drug, and prohibit the import of the said drug or class of drug after expiry of a specified period from the date of manufacture;

(h) regulate the submission by importers, and the securing of samples of drugs 1[or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis;

(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs 1[or cosmetics] sought to be imported, the procedure of officers of Customs in dealing with such evidence, and the manner of storage at places of import of drugs 1[or cosmetics] detained pending admission;

(j) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter and the rules made thereunder of drugs 1[or cosmetics] imported for the purpose only of the transport through, and export from 2[India];

(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs 1[or cosmetics] 3[including the use of packing material which comes into direct contact with the drugs];

(l) regulate the mode of labeling drugs 1[or cosmetics] imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;

(m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder;

(n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary medicine containing such drug;

(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder of any specified drug or class of drugs 1[or cosmetic or class of cosmetics.]

4[13. Offences-(1) Whoever himself or by any other person on his behalf imports,-
(a) any drug deemed to be adulterated under Section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in Section 9D or any cosmetic of the nature referred to in clause (ee) of Section 10 shall be punishable with imprisonment for a term which may be extend to three years and a fine which may extend to five thousand rupees;

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited under Section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees or with both;

(c) any drug or cosmetic in contravention of the provisions of any notification issued under Section 10A, shall be punishable with imprisonment for a term which may extend to three years or with fine which may extend to five hundred rupees, or with both.

(2) Whoever having been convicted of an offence -
(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to ten thousand rupees, or with both;

(b) under clause (b) of sub-section (1) is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees, or with both.

(3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provisions of Section 11.]

14. Confiscation - When any offence punishable under Section 13 has been committed, the consignment of the drugs 1[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.

21. In this Part-

(a) 'Import licence' means either a licence in Form 10 to import drugs, excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X);

(b) "licensing authority" means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and included any person to whom the power of a licensing authority may be delegated under Rule 22;

(c) "licence for examination, test or analysis" means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis.

(d) "manufacturer", includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and/or in other major countries;

(e) Registration Certificate" means a certificate issued under rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India'.

22. The licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licences and Registration Certificates, and such other powers as may be specified in the order to any other person under his control.

23. Import licences - An import licence in Form 10 shall be required for import of drugs excluding those specified in Schedule X, and an import licence in Form 10-A shall be required for the import of drugs specified in Schedule X.)

24. Form and manner of application for import licence - (1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these rules, or by the manufacturer's agent in India either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one -3- hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer:

Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug.

(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under rule 27-A: Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under rule 27-A, for reasons to be recorded in writing."

(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this rule, if the original is defaced, damaged or lost.

24-A. Form and manner of application for Registration Certificate -

(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid whole sale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence -4- manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules and shall be accompanied by the fee specified in sub-rule (3) and the information and undertakings specified in Schedules D-1 and D-II duly signed by on behalf of the manufacturer.

(2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate.

(3) (i) A fee of one thousand and five hundred US dollars shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India.

(ii) A fee of one thousand US dollars shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug:

Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars for each drug.

(4) The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104- Fees and Fines".

Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines", and the original receipt of the said transfer shall be treated as an equivalent to the bank challan subject to the approval by the Bank of Baroda that they have received the payment.

(5) The applicant shall be liable for the payment of a fee of five thousand US dollars for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under rule 22:

(6) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.

(7) A fee of three hundred US dollars shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost."

(8) No Registration Certificate shall be required under these rules in respect of an inactive bulk substance to be used for a drug formulation, with or without Pharmacopoeial conformity."

i) the premises, where the imported substances will be stocked are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and

ii) the occupation, trade or business ordinarily carried out by the applicant: Provided that the licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,-

(a) that the applicant has not complied with the provisions of the Act or these rules, or

(b) that by reasons of-

(i) his conviction under the Act or these rules or the Narcotic Drugs and Psychotropic Substances Act, (61 of 1985 ) or the rules made thereunder;

(ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted.

(2) Any person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit.

25-B. Registration Certificate for import of drugs manufactured by one manufacturer - (1) A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer:

Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit: Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.

1. Name of the drug,
2. Batch Number,
3. Name and address of the manufacturer.
4. Date of transaction.
5. Opening stock on the business day,
6. uantity of drug received, if any, and the source from which received,
7. Name of the purchaser, his address and licence number,
8. Balance quantity of drug at the end of the business day,
9. Signature of the person under whose supervision the drugs have been supplied;)

(vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licences, as may be specified in any Rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months' notice.

27. Grant of import licence - On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall on being satisfied, that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or Form 10-A, as the case may be.

27-A. Grant of Registration Certificate - (1) On receipt of an application for Registration Certificate in the Form and manner specified in rule 24-A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41:

Provided further that if the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months as the licensing authority, may deem fit.

(2) If the applicant does not receive the Registration Certificate within the period as specified in provisio to sub rule (1), he may appeal to the Central Government and the Central Government may after such enquire into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.

28. Duration of import licence — A licence, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from date of its issue.

Provided that if an application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.

28-A. Duration of Registration Certificate — A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue:

Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.

29. Suspension and cancellation of import licence — If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:

Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity for representing his views, pass such orders in relation thereto as it thinks fit.

29-A. Suspension and cancellation of Registration Certificate — If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:

Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.

30-B. Prohibition of import of certain drugs — No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.)

31. Standard for certain imported drugs — No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall be applicable for determining whether any such imported drug complies with the said standards:

Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:

Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent. residual shelf-life period as on the date of import:

Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow, the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.

32. Packing and labelling of imported drugs — No drug shall be imported unless it is packed and labelled in conformity with the rules in Parts IX and X and further conforms to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform to the rules in Parts IX and X and Schedule F(1).

32-A. Packing and labelling of Homoeopathic medicine — No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.

33. Import of drugs for examination, test or analysis — Small quantities of drugs the import of which is otherwise prohibited under Section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:

(a) No drug shall be imported for such purpose except under a licence in Form 11;

(b) The licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorize;

(c) The licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof;

(d) The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation, and the name of the manufacturer;

(e) The licensee shall comply with such further requirements, if any, applicable to the holders of licences for examination, test or analysis as may be specified in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice.

33-A. Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients — Small quantities of a new drug, as defined in rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:
(a) no new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin;

(b) the licencee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorise;

(c) the licencee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof;

(d) the licencee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease;

(e) the licencee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice;

(f) the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist;

(g) the quantity of any single drug so imported shall not exceed 100 average dosages per patient:

Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug a larger quantity.

'34-A. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients — (1) An application for an import licence for small quantities of a new drug, as defined in rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or -21- such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be.

(2) The licensing authority may require such further particulars to be supplied, as he may consider necessary.

(3) Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.

(4) fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other branch or branches of Bank of Baroda, or any other Bank, as Notified, from time to time, by the Central Government, to be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fine

35. Cancellation of licence for examination, test or analysis — (1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued.

(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months of the date of the order.

35-A. Cancellation of licence for import of small quantities of new drugs —
(1) A licence for import of small quantities of a new drug, defined in rule 122-E, for the purpose of the treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder.

(2) A licencee whose licence has been cancelled may appeal to the Central Government within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit."

36. Import of drugs for personal use — Small quantities of drugs, the imports of which is otherwise prohibited under Section 10 of the Act, may be imported for personal use subject to the following conditions: (i) the drugs shall form part of a passenger's bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;

(ii) the drugs shall be declared to the Customs Authorities if they so direct;

(iii) the quantity of any single drug so imported shall not exceed one hundred average does: Provided that the licensing authority may in an exceptional case in any individual case sanction the imports of a large quantity: Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:

i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use;

ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner; and

iii) the licensing authority grants a permit in respect of the said drug in Form 12-B.

37. Packing of patent or proprietary medicines — Patent or proprietary medicine shall be imported in containers intended for retail sale:

Provided that such medicine may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission.

38. Statement to accompany imported drugs — All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the name and quantities of the drugs.

39. Documents to be supplied to the Customs Collector — Before drugs for the import of which a licence is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall be supplied to the Customs Collector.

40. Procedure for the import of drugs — (1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions of Chapter III of the Act and Rules thereunder he may, and if requested by an officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government on such samples is received:

Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall make over the consignment to the importer.

(2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required by the Customs Collector to return the consignment or any portion thereof he shall return the consignment or portion thereof within ten days of receipt of the notice.

41. (1) If the director of the laboratory appointed for the purpose by the Central Government or any other empowered by him on this behalf subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall them to be destroyed.

Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final.

(2) If the director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorised in this behalf by the Central Government.

43. The drug specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule.

43-A. No drug shall be imported into India except through one of the following places, namely:

Firozepur Cantonment and Amritsar Railway Stations:

In respect of drugs imported by rail across the frontier with Pakistan. Ranaghat, Bongaon and Mohiassan Railway Stations:
In respect of drugs imported by rail across the frontier with Bangladesh.
Raxual: in respect of drugs imported by road and railway lines connecting Raxual in India and Birganj in Nepal.
Chennai, Calcutta, Mumbai Cochin and Nhava Sheva.
In respect of drugs imported by sea into India
Chennai, Calcutta, Mumbai, Delhi Ahmedabad and Hyderabad.
In respect of drugs imported by air into India.

43-B. Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder:

Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences.

"FORM 8
(See rule 24)
Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945.
--------

*
I / we _______________________________________________, (full address with telephone number, fax number and e-mail address) hereby apply for a licence to import drugs specified below manufactured by M/s __________________________________ (full address with telephone no, fax and e-mail no.)

2. Names of the drugs to be imported:
(1)
(2)
(3)

*
3 I/we _______________________________________________enclose herewith an undertaking in Form 9 dated ____________ signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics Rules, 1945.

4. I/we _______________________________________________enclose herewith a copy of Registration Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No __________________________ Dated______________ issued through
M/s_______________________________________________ (name and full address _____________________________________________ valid upto _________________.

5. I/we _______________________________________________ hold a valid wholesale licence for sale or distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and rules made thereunder. A copy of the said licence is enclosed.

6. A fee of_______________ has been credited to Government under the Head of Account "0210 - Medical and Public Health, 04- Public Health,104- Fees and Fines" under the Drugs and Cosmetics Rules, 1945 - Central vide Challan No.____________, dated ____________ (attachedin original ).

Licence Number _________________ Date _______________

____________________________ _________________________________ (Name and full address of the importer) is hereby licensed to import into India during the period for which this licence is in force, the drugs specified below, manufactured by M/s _____________________________________ (name and full address) and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from _________________ to_______________ unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported:

Place:____________

Date :____________

1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, and the original licence shall be produced, whenever required.

2. Each batch of drug imported into India shall be accompanied with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer in India alongwith the registration holder and his authorised agent.

4. The licencee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution";

Quantities which may be imported
Licensing Authority

Form 12
[See Rule 34]
Application for licence to import drugs for
purpose of examination, test or analysis

I _____________________________resident of ___________ by occupation __________ hereby apply for a licence to import the drugs specified below for the purposes of examination, test or analysis at _____________ from ___________ and I undertake to comply with the conditions applicable to the licence.

A fee of rupees of fifteen has been credited to the Government under the Head of Account “0210- Medical & Public Health, 04-Public Health, 104-Fees & Fines” under the Drugs & Cosmetics Rules, 1945-Central vide treasury receipt attached.

Names of drugs and classes of drugs                                            Quantities

Date: __________________                             Signature: ______________

Form 12-A
[See Rule 36, Second Proviso]
Application for the issue of a permit to
import small quantities of drugs for personal use

I _____________________________ resident of _____________ by occupation _______________ hereby apply for a permit to import the drugs specified below for personal use from ___________________

I attach a prescription from a registered medical practitioner in regard to the need for the said drugs.

Names of drugs                                                                                         Quantities

Date_______________                                                    Signature_____________

FORM 12-AA
(See rule 34A)
Application for licence to import small quantities of new drugs by a Government
Hospital or Autonomous Medical Institution for the treatment of patients.
--------------------------

I, ___________(name and designation) ____________________________of ___________________________________________________  (name of the Hospital/Autonomous Medical Institution)hereby apply for a licence to import small quantities of new  drugs specified below for the purpose of treatment of patients for the disease __________________(name of the disease)  at  _____________________________________________ (name and place of the hospital) and I undertake to comply with the conditions applicable to the licence and other provisions of  the Drugs and Cosmetics Act , 1940 and the rules made thereunder, from time to time.

1.                  A fee of rupees_________________ has been credited to Government under the Head of Account  “0210- Medical and Public Health, 04- Medical and Public Health, 104- Fees and Fines” under the Drugs and Cosmetics Rules, 1945 – Central vide Challan No.________, dated ________, (attached in original).

2.                  Name of new drug to be imported: -

Place: __________________

Date: __________________                              

Signature ____________________________

Name_______________________________

Seal/Stamp___________________________

CERTIFICATE

        Certified that the drugs specified above for import are urgently required for the treatment of patients suffering from________________________________and that the said drug(s) is /are not available in India.

SIGNATURE ______________________

Medical Superintendent of the Government Hospital/Head of

Autonomous Medical Institution

Seal/Stamp;

Place: _____________

Date: _____________

Form 12-B
[See Rule 36, Second Proviso]
Permit for the import of small quantities of drugs for personal use.

1. __________________________________ of ______________________ is hereby permitted to import from ______________the drugs specified below for personal use.

2. This permit is subject to the conditions prescribed in the Rules under the Drugs & Cosmetics Act, 1940.

3. This permit shall, unless previously suspended or revoked, be in force for a period of six months from the date specified below.

Names of drugs                                                  Quantities which may be imported

Date________________                                                         Licensing Authority.