Recent Amendments

Standards of Weights and Measures (General) Third Amendment Rules, 2005-
GSR 351(E) Dated 02.06.2005: The Central Government, vide this notification, has made the Standards of Weights and Measures (General) Third Amendment Rules, 2005, further to amend the Standards of Weights and Measures (General) Rules, 1987. The amendments specified general, performance, efficiency and mechanical and electrical safety requirements, including test methods for type approval, for non-invasive mechanical and electronic or automated sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure.

Central Excise Notification No: 04/ NT (23-Feb-05) Amendments in the Ntf No. 2/2005-CE(N.T.), dt. 07/01/2005-
In the said notification, in the Table,-
(i) against S.No.1, for the entry in column (4), the entry `40%` shall be substituted; and
(ii) against S.No.2, for the entry in column (4), the entry `40%` shall be substituted.

The Industries (Development and Regulation) Act, 1951 (65 of 1951)-
SO 1386(E) dated 23.9.2005-In exercise of the powers conferred by Sub-section (1) of Section 29B of the Industries (Development and Regulation) Act, 1951 (65 of 1951) the Central Government made the following further amendment in the notification of the Government of India in the erstwhile Ministry of Industry, Department of Industrial Development, number, S.O. 477(E), dated the 25th July, 1991,in Schedule-II relating to list of industries in respect of which industrial licensing is compulsory. Item number 16 shall be omitted which relates to Drugs and Pharmaceuticals (According to Drug Policy) and the entries relating thereto.

Drugs (Prices Control) Order, 1995

SO 1490(E) dated 17-10-2005-The NPPA in its Order No.S.O. 1333(E) dated 16.9.2005 replaced "Chloroquine Phosphate Injection” as “Chloroquine Phosphate Syrup/Suspension", in order No.S.O.1345(E) dated 16.9.2005 replaced "Dextropropoxyphene+Diclofenac+Paracetamol Capsules” as “Dextropropoxyphene+ Diclofenac+Paracetamol Tablets" in another Order No.S.O.1353(E) dated 16.9.2005 replaced   "Sulphamethoxazole 180mg.” as “Sulphamethoxazole 800 mg" and in Order No. S.O.1358(E) dated 16.9.2005 replaced "Each ml contains” as “Each 5 ml contains"

Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)

GSR 104 (E) dated 25th Feb, 2005-In exercise of the powers conferred by Section 9, read with Section 76 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985,in the Rule 67 in sub-rule (1), for the word and figure 'Form 7", the word and figure 'Form 6" shall be substituted; after sub-rule 4, the following proviso shall be inserted, namely:- "Provided that consignment note in Form 6 shall not apply in cases where the sale of the psychotropic Substance is accompanied by a sale bill or invoice or cash memo or any other document duly signed by the consignor or his authorized signatory, which shall include the following information about the consignment: (a) name, address and licence number of the consignor and the consignee; (b) description, batch number and quantity; (c) mode and particulars of transport: Provided further that such document shall be preserved by consignor and consignee for a period of two years for inspection by the officers referred to in sub-rule (4) above.

The Narcotic Drugs and Psychotropic Substances Rules, 1985

GSR 736 (E) Dated 22.12.2005-Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2005 published to insert in Rule 36 (2A) after “Pholcodine and their respective salts” the words “from Indian opium, if the Central Government determines that such licence is necessary in public interest and is in consonance with India’s obligations under International treaties, conventions or protocols” .

GSR 633(E) dated 17-10-2005-In pursuance of rule 8 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government notified general conditions for grant of licence for cultivation of opium poppy on account of the Central Government during the Opium Crop year commencing on the 1st day of October, 2005 and ending with the 30th day of September, 2006.

GSR 634(E) dated 17-10-2005-In pursuance of Rule 5 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government notified tracts in the States of Madhya Pradesh, Rajasthan and Uttar Pradesh as the tracts within which poppy may be cultivated on account of the Central Government during the opium year commencing on the 1st day of October, 2005 and ending on the 30th September, 2006.

The Medical Termination of Pregnancy Rules, 2003-
GSR 50(E) dated 30th December, 2004: The Central Government, vide this notification notified the drugs and parenteral fluids, facilities & additional drugs for emergency use and treatment for places approved for conducting termination of pregnancy, under Section 4 of the Medical Termination of Pregnancy (Amendment) Act, 2002 (64 of 2002).[Published in the Gazette of India (extraordinary) Part-II, section 3, sub-section (ii) vide Issue No. 39, dated 13.1.2005.]

Patents (Amendment) Rules, 2005
Notification No. SO1418(E) Dated 28.12.2004:
The Central Government, vide this notification, has brought to the fore, the Patents (Amendment) Rules, 2005, amending the Patents Rules, 2003. These Rules shall come into force, from the 1st day of January, 2005.

Pre–Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Act, 2002 (14 of 2003),Enforcement Date 
Notification No.SO175(E) Dated 14.02.2003 : The Central Government has appointed the 14th day of February, 2003 as the date on which the Pre–Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Act, 2002 shall come into force.

Prevention of Food Adulteration (5th Amendment) Rules, 2005
GSR 646 (E) Dated 20.10.2005: The Central Government, after consultation with the Central Committee for Food Standards, makes the Prevention of Food Adulteration (5th Amendment) Rules, 2005 further to amend the Prevention of Food Adulteration Rules, 1955. These rules shall come into force after two years from the date of publication in the Official Gazette. The amendments relate to Rule 50 of the Prevention of Food Adulteration Rules, 1955.

GSR 591(E) - Corrigendum Dated 27.09.2005-Prevention of Food Adulteration Corrigendum No: GSR 591(E) Dated 15.09.2005, Amendments in Notifications G.S.R.809(E), and G.S.R.417(E)-In the Table, in serial No.2 Aspartame (methylester), entry against `Soft Drink concentrate`in the column 4, for the words and figures `7000 PPM`, read the words and figures`*700 PPM`.

GSR 595(E) - Corrigendum Dated 27.09.2005-Prevention of Food Adulteration Corrigendum No: GSR 595(E) Dated 19.09.2005 Amendment in Notification No. G.S.R.184(E)-In Table No.13 in Serial No.J. under Sub-Serial 6. for the words, `Calcium/Magnesium/Sodium salts of Stearic Acid.` the following shall be substituted, namely, `Calcium/Magnesium/Sodium Salt of Stearic Acid. Stearic Acid (food grade)`.

GSR 596(E) - Corrigendum Dated 27.09.2005-Prevention of Food Adulteration Corrigendum No: GSR 596(E) Dated 20.09.2005) Amendments in Notification No. G.S.R 185(E)-In Table 9, the name of the product occurring in the column heading. the words `Concentrated fruit/vegetable juice, pulp. puree with preservatives`. shall read as `Concentrated fruit/vegetable juice. pulp, puree with preservatives for industrial use only.`
 

Prevention of Food Adulteration (Fourth Amendment) Rules, 2005
GSR 356(E) Dated 07.06.2005:
The Central Government, after consultation with the Central Committee for Food Standard, has made the Prevention of Food Adulteration (Fourth Amendment) Rules, 2005, further to amend the Prevention of Food Adulteration Rules, 1955. The amendments concentrated on packaged milk products and packaged frozen deserts/ confections prescribing new regulations pertaining to these food products.

Prevention of Food Adulteration (2nd Amendment) Rules, 2004
GSR451 (E) Dated 15.07.2004:
The Central Government vide the said notification makes the Prevention of Food Adulteration (2nd Amendment) Rules, 2004. These Rules amend the Prevention of Food Adulteration Rules, 1955 which prescribes the standards for Packaged Drinking Water. The Prevention of Food Adulteration (2nd Amendment) Rules, 2004 makes it clear that CARBONATED WATER means water conforming to the standards prescribed for Packaged Drinking Water under Prevention of Food Adulteration Rules, 1955 and impregnated with carbon dioxide under pressure.

Prevention of Food Adulteration (5th Amendment) Rules, 2003
GSR831(E) Dated 21.10.2003 :
In the Prevention of Food Adulteration Rules, 1955, in rule 42:-

(i) In sub-rule (ZZZ)(14), after the declaration, PACKAGED DRINKING WATER the following declaration has been inserted, -

"One time usable plastic bottles of packaged drinking water shall carry the following declaration

"CRUSH THE BOTTLE AFTER USE"

(ii) In sub-rule (ZZZ)(15), after the declaration NATURAL MINERAL WATER the following declaration has been inserted, -

"One time usable plastic bottles of mineral water shall carry the following declaration

"CRUSH THE BOTTLE AFTER USE"


Prevention of Food Adulteration (4th Amendment)Rules,2003
   

GSR832(E) Dated 21.10.2003 : In the Prevention of Food Adulteration Rules, 1955 :-

(i) in rule 13, in sub-rule (1), in the proviso, the words "above the age of eight years", has been omitted.

(ii) for rule 51, the following rule has been substituted, namely:-

"51 Duration of Licences: - A licence shall, unless sooner suspended or cancelled, be in force for a period of five years or for such period as the State Government may prescribe:

Provided that the licensee shall make an application for renewal of licence at least three months before the expiry of the period of validity of the licence and the licensing authority shall pass orders on the application before the expiry period of validity of the licence in force.

(iii) in appendix 'A', after FORM VIII, a new FORM has been inserted namely "FORM-IX".

Prevention of Food Adulteration (Amendment) Rules, 2002

GSR101(E) Dated 11.02.2003 : The Draft of Prevention of Food Adulteration (Amendment) Rules, 2002 has been published whereunder the following amendments are proposed in Prevention of Food Adulteration Rules, 1955,

(i) In Rule 13, in proviso to sub-rule (1), the words "above the age of eight years", shall be omitted

(ii) Rule 51 relating to Duration of Licences shall be substituted.

(iii) In Appendix 'A' Form IX shall be inserted.

GSR771(E) Dated 29.09.2003 : Central Government has made the Prevention of Food Adulteration (Third Amendment) Rules, 2003 further to amend the Prevention of Food Adulteration Rules, 1955 to be enforced from 29.09.2003.

Homoeopathy Central Council Act, 1973

Notification No. SO144(E) Dated 07.02.2003
: In the Second Schedule, under the heading "KERALA", as against serial number 9A relating to UNIVERSITY OF CALICUT, KERALA, in columns 2, 3 and 4, after the entries, the entry relating to Bachelor of Homoeopathic Medicine and Surgery has been inserted.

Drugs and Cosmetics Act, 1940

GSR 701 (E) Dated 1.12.2005-In exercise of the powers conferred by Section 33-F (i) of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government appointed Director, Pharmacopoeial Laboratory for Indian Medicines, Ghaziabad as Government analyst for the whole of India in respect of Ayurvedic, Siddha and Unani medicines.

SO 1468 (E) dated 6.10.2005-In pursuance of the sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), Central Government, after consultation with the Drugs Technical Advisory Board, specifies Sterile Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, IV Canula, Bone Cements, Heart Valves, Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic Replacements intended for external or internal use in human beings as drugs with immediate effect.

SO 1406(E) dated 23.9.2005-In exercise of the powers conferred by section 33-D of the Drugs and Cosmetics Act 1940(23 of 1940) the Central Government constituted the Ayurved, Siddha and Unani Drugs consultative Committee consisting of the representative of the Central Government, State Government and Union territories.

GSR 510(E) Dated 25th Jul 2005 - In exercise of the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government has prohibited the manufacture, sale or distribution of Valdecoxib and its formulations for human use with immediate effect.

SO (E) dated In exercise of powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2004-09 and Paragraph 1.1 of the Handbook of Procedures (Vol.I), the Director General of Foreign Trade hereby made amendments and additions in the Handbook of Procedures (Vol.I) for free Sale and Commerce Certificate for export of items not covered under Drugs & Cosmetics Act, 1940, which have usage in hospitals, nursing homes and clinics, etc. for medical and surgical purposes and are not prohibited for export.

Importability of Boric Acid-
Circular No: 61/2004 Dated 28.10.2004: The Central Board of Excise and Customs vide Circular No: 61/2004 Dated 28.10.2004 notifies that after due consultations with the Department of Agriculture and Cooperation it has been decided that it is a precondition for import of Boric Acid that the importers of the same should register with the Central Committee (CIB & RC) Insecticides Board & Registration under the provisions of the Insecticides Act, 1968. In case Boric Acid is to be imported for an identified non-insecticidal use then such imports would be exempted from the requirements of registration provided a certificate of end use is issued by the concerned Administrative Ministry/Department of the Government of India.

Import of Penicillin and 6-APA under Advance Licencing Scheme-
Public Notice No: 6/2004-09 Dated 17.09.2004: By virtue of the above public notice, the Director General of Foreign Trade General notifies the amendment in the Handbook of Procedures (Vol.2), 2002-07 under the heading "General Note for Chemicals & Allied Products" regarding import of Penicillin and its salts (ITC HS Code No.29411010). The public notice states that whenever import of Penicillin and its salts is allowed as an input item under Duty Exemption Scheme, the export obligation period for such licences shall be restricted to six months from the date of clearance of first import consignment and that the licensing authority shall make an endorsement in the Advance Licence to this effect.

Import of Approved and Unapproved Drugs under the Advance Licensing Scheme Exemption from Registration Procedure-
Circular No: 41(RE-2004)/2002-2007 Dated 22.07.2004: The Directorate General of Foreign Trade vide the above circular lays down conditions for Import of Approved and Unapproved Drugs under the Advance Licensing Scheme. It states that no advance licence shall be issued for a period of 30 days from the date of issue of this Policy Circular for import of Penicillins and its salts and that wherever import of Penicillins and its salts is allowed under the advance licensing scheme, export obligation period for such licences shall be restricted to three months from the date of clearance of import of first consignment and wherever Advance Licences have already been issued for import of the sameno further Export Obligation period extension shall be granted. Previously. the DGFT had allowed import of approved and unapproved drugs under Advance Licencing Scheme without requirement of registration procedure under Drugs and Cosmetics Act.


Clarification on Import of Approved and Unapproved Drugs under the Advance Licensing Scheme-
Circular No. 33 (RE-2004)/2002-2007 Dated 30.04.2004 : In continuation of Policy Circular No. 9(RE-2004)/2002-2007 dated 30.6.2003 and No.15(RE-2004)/2002-2007 dated 17.9.2003. whereby import of approved and unapproved drugs were allowed without the requirements of registration procedure under the Drugs and Cosmetics Act etc., it has been further clarified that the import of bulk drugs in terms of Para 4.2.7 of the EXIM Policy,2002-07 is allowed without the requirement of manufacturing site registration and import licence as required under Ministry of Health Notification No.GSR 604(E) dt. 24.8.2001.

Exemption From Registration Procedure For Import Of All Types Of Approved And Unapproved Drugs Under The Advance Licensing Scheme-
Circular No. 15(RE-03)/2002-2007 Dated 17.09.2003
: Clarifications have been issued regarding exemption from Registration Procedure For Import Of All Types Of Approved And Unapproved Drugs Under The Advance Licensing Scheme. 

GSR780(E) Dated 1st Oct2003 - In exercise of the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government has prohibited the manufacture, sale or distribution of Phenformin for human use.

GSR 100 (E) dated 11th February, 2003- fixed dose combinations of Rifampicin, Isoniazid and Pyrazinamide except those, which provide daily adult dose of minimum and maximum dose of 450 mg to 600 mg, 300 mg to 400mg and 1000mg to 1500mg respectively.

GSR 191(E) dated 5th March, 2003-prohibits the Manufacture of Astemizole and terfinadine for human use with immediate effect and sale and distribution thereof with effect from 1st April, 2003.

SO 111(E) dated 31st January, 2003-The Drugs Technical Advisory Board reconstituted effective from 31.3.2003

Drugs and Cosmetics Rules, 1945

GSR 735 (E) Dated 21.12.2005-Drugs and Cosmetics (8th Amendment) Rules, 2005 published to substitute Part I in the Schedule O of the Drugs and Cosmetics Rules, 1945 with a new entry.

GSR 734 (E) Dated 21.12.2005-Drugs and Cosmetics (7th Amendment) Rules, 2005 published to isert in the Drugs and Cosmetics Rules, 1945, in Schedule K, after Serial Number 33 and the entries relating thereto, a new entry No (34) shall be inserted relating to Exemption for Production of Oxygen 93 % USP.

GSR 733 (E) Dated 21.12.2005-Drugs and Cosmetics (6th Amendment) Rules, 2005 published . In Rule 122 F (1) ‘Explanation’ is omitted and Rule 122G shall be numbered as sub-rule (1) thereof, and after sub-rule (1) as so renumbered, new Sub-rule (2) is inserted.In Schedule F, Part XII-B under the heading J. SPECIAL REAGENTS’, for the entry at serial number (5), the entry “(5) ELISA or Rapid or RPHA test kits for Hepatitis and HIV I and II.” shall be substituted.

GSR 732 (E) Dated 21.12.2005-Draft of certain rules further to amend Rule 2 (b) of the Drugs and Cosmetics Rules, 1945, in exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is published.

GSR 705 (E) Dated 28.11.2005-In the notification No. G.S.R. 463(E), dated 8th July, 2005, published in the Gazette of India, (Extraordinary), Part II, Section 3, Sub-section (i), dated the 8th July, 2005. The word “Rules” may be read instead of words “Draft Rules”.

GSR 691 (E) dated 24.11.2005-Central Govt proposes to insert new Rule 161 B and Shelf life/ date of expiry of Ayurveda, Siddha and Unani (ASU) medicines.

GSR 674 (E) Dated 10.11.2005-The Central Govt made amendment in Rule 160 B (2) (ii) (b) by prescribing qualifications for Expert, Chemist and Botanist (Pharmacognosist)

GSR 627 (E) dated 7.10.2005-In pursuance of provisions of sub-rule (1) of rule 68A of Part VII of the Drugs and Cosmetics Rules, 1945, the Central Government hereby specifies the Sterile Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, IV Canula, Bone Cements, Heart Valves, Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic Replacements drugs to be licensed for manufacture, for sale or distribution by the Central Licence Approving Authority appointed by the Central Government. Amended vide GSR 664 (E) dated 14.11.2005-In the notification  in fourth line, the words, “manufacture, for sale or” shall be read as “manufacture for sale or”.

GSR 431 (E) dated 30.6.2005:- Drugs and Cosmetics (5th Amendment) Rules, 2005-Vide this notification the Central Govt has notified certain changes in Note, PART 1 under the heading Good Manufacturing Practices for Premises and Manufacturing Practices for Premises and Materials, 3.Production area, 7.Health, Clothing and Sanitation of workers, 8.Manufactring operations and controls, 25.Distribution records, Part 1A and Part II.

GSR 285 (E) dated 11.5.2005:- Drugs and Cosmetics (Vth Amendment) Rules, 2005-Vide this notification the Central Govt inserted a new Rule 169 after Rule 168 for Permitted Excipients. This has come into force from 11.5.2005.

GSR 312 (E) dated 16.5.2005:- Draft Rules to amend Drugs and Cosmetics Rules, 1945 are published, proposing to insert Rule 163.A to 163.G, Form 1-A and 2-A to work Pharmacopoeial Laboratory for Indian Medicines to function as Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha and Unani drugs.

GSR 174 (E) dated 16.3.2005:- The Central Govt has amended Schedule 'P'.Under the heading 'Other Vaccines' for serial number 2 and the entries relating thereto and under the heading 'Miscellaneous Drugs', for serial number 1 and the entries relating thereto.

GSR 105 (E) dated 24th Feb, 2005:-Central Govt has published draft Rules to substitute existing Shedule H to the Drugs and Cosmetics Rules, 1945

GSR 79 (E) dated 14.02.2005- Central Govt notified certain changes in Rule 153, 153-A, 156 and 156-A of the Drugs and Cosmetics Rules, 1945

GSR 51 (E) dated 02.02.2005-Central Govt notified certain changes 1945 in the Schedule O, for Part I namely:-"Provisions applicable to black fluids and white fluids-The standards for disinfectants shall conform to the Indian Standards specification (IS 1061 : 1997) laid down from time to time by Bureau of Indian Standards."

GSR 32 (E) dated 20.1.2005:-Central Govt substituted existing Schedule Y to the Drugs and Cosmetics Rules, 1945. This Schedule mainly deals with clinical Trials in India.

GSR 35(E) Dated 20.01.2005:-The Central Government has further amended the Drugs and Cosmetics Rules, 1945, adding proviso that Registration certificate shall not be required to be accompanied with an application for an import licence under the rules for the import of in-vitro diagnostic kits and regents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3. A corrigendum is issued Vide GSR 669 (E) Dtaed 17.11.2005 to this notification.

GSR 648 (E) dated 16th September, 2002-Certain additional Chemical contraceptives and First Aid Kits supplied with motor vehicle exempted under Schedule K.

GSR 73(E) dated 31st January, 2003-Concept of approved public testing Laboratories introduced for testing of drugs from Indian System of Medicine.

GSR 76 (E) dated 3rd February, 2003-qualifications for the State Drug Licensing  and Controlling Authority for Indian System of Medicine prescribed under Rules 162-A.  

GSR 549 (E) dated 16th July, 2003-in Schedule K after Serial Number 32, entry number 33 is added vide which Nicotine gum containing upto 2 mg of nicotine are exempted from Provisions of Chapter IV of the Act.

Indian Extradition Act 1962 (34 of 1962)-

Applicability of the Provisions of Extradition Act 1962 Except Chapter III, to Italy-
Order No. GSR707(E) Dated 04.09.2003 : In the exercise of the power conferred by sub-section 4 of section 3 of the Indian Extradition Act 1962 (34 of 1962), the Central Government has directed that the provision of the said Act, other than Chapter III, shall apply to Italy with effect from the date of publication of this notification, in respect of the offences specified in the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substance.

Exemption From Registration Procedure For Import Of All Types Of Approved And Unapproved Drugs Under The Advance Licencing Scheme
Trade Notice No. 05 / 2002-2007 Dated 08.10.2003: With a view to smoothly implement the provisions of the Policy Circulars No.9(RE-2003)/2002-07 dated 30.6.2003 and Policy circular No.15(RE-2003)/2002-2007, the members of trade and Industry have been informed of the procedure to be followed while making applications for grant of a fresh Advance Licence involving import of all drugs or while applying for grant of revalidation/extension in Export Obligation period/seeking enhancement in quantities in respect of an already issued Advance Licence.

Biological Diversity Rules, 2004
Notification No. GSR261(E) Dated 15.04.2004 : The Central government has framed the Biological Diversity Rules, 2004 to set out a provisions for appointment of chairperson for National Biodiversity Authority. Moreover the said rules provides the provisions for Pay & allowances to the chairperson. The rules describes that the said authority shall meet at least four times in a year normally after a period of three months at the Head quarters of the Authority or at such place as may be decided by the Chairperson.

Special Economic Zone Rules, 2003, and Special Economic Zone (Customs Procedure) Regulations, 2003-

Operationalisation of the Provision of Chapter X A of the Customs Act, 1962
Circular No. 33/2004 Dated 12.05.2004
: Chapter XA of the Customs Act, 1962, containing the Special Provisions Relating To Special Economic Zone, has been made effective from 11-05-2004. The impact of the same has been made on Special Economic Zone Rules, 2003, and Special Economic Zone (Customs Procedure) Regulations, 2003. The said rules & regulations were notified earlier on 22.07.2003 but these have also been made effective from the 11.05.2004.