GRANT OR RENEWAL OF LICENCE TO MANUFACTURE LARGE VOLUME PARENTERALS (I.V. FLUIDS)/SERA AND VACCINES UNDER DRUGS AND COSMETICS RULES, 1945 - PROCEDURE THEREOF

In the year 1996, Govt. of India took one more leap forward to streamline, rationalize and restructure the procedure for grant or renewal of licences to manufacture 2 of 3 notified drugs especially the large volume parenterals (I.V. Fluids) and Sera and Vaccines by publishing a notification, GSR 119 (E) dt. 11.3.96, and hence amending provisions of different rules under the Drugs & Cosmetics Act, 1940 which governs the licensing of these two categories of notified drugs.

2. Through this notification the following changes, by way of substitution/insertions, have been carried out:

A. Rule 75:
Sub-Rule (3) under the said rule has been inserted for making an exclusive application on Form 27D for LVPs/Sera and Vaccines to the State Licensing Authority (SLA) which shall be accompanied by a licence fee of Rs. 6000 and an inspection fee of Rs. 1500 for the purpose of obtaining a fresh licence or renewal of licences. The licences shall be issued /made upto ten items. Rule 75(5) further requires that if the licensee applies for manufacture of more than ten items of each category of drugs, the application shall be accompanied by an additional fee at the rate of Rupees three hundred for each additional item of drugs.

B. Rule 76 :
(a) In the text of the said rule, a substitution has been made for issue of licence on Form 28D for manufacture of LVPs/Sera and Vaccines in case a new/fresh licence is sought from the SLA.

(b) At the end of rule 76, an EXPLANATION has been inserted defining what shall be considered as LVPs and how these can be differentiated from other forms of injectables (Small Volume Parenterals (SVPs) Although LVP is a sterile preparation with a volume of 100 ml or more in one container of the finished dosage form intended for single use but ACDs have also been included under the said definition of LVP.

(c) Rule 77, 78, 81 83, 84A are the consequential changes with regard to grant or renewal of licences. Rule 77 stipulates that the licences shall be valid for period of five years on and from the date on which it is granted or renewed.

(d) Procedural legislation for grant or renewal of licences in the earlier rules required that both for LVPs SVPs the mode of application, forms for grant or renewal of licences were on Form 28 or on 26 as well as having one fee structure.

With the advent of new legislation the mode of application, grant or renewal of licences for LVPs have been made exclusively together with fee structure. The procedural details are as under :

(a) MODE OF APPLICATION ON FORM 27D
The prospective applicant or for that matter the company which is already licensed shall have to make an application on Form 27D in triplicate accompanied by a plan of the premises list of equipments and machinery to be employed for manufacture and testing; Memorandum of Association/Constitution of the firm; copies of qualifications and experience of competent technical staff and documents relating to ownership or tenancy of the premises.

A copy of the application together with the relevant enclosures shall have to be submitted separately to the following authorities :

(i) State Licensing Authority (SLA)
(ii) Central Licence Approving Authority (CLAA)
(iii) Concerned Zonal/Sub-Zonal Officers of CDSCO

The list of items indicating names of the drugs should clearly specify the composition in terms of 100 ml, Pharmacopoeial specification as well as packsizes under which each item is intended to be manufactured.

For new applicants it is necessary that the exact date on which the Unit shall be ready for inspection would be indicated.

The above procedure has been devised for submitting application in triplicate to the different Authorities involved with a view to cut down the gestation period for quick disposal by any one of them the grant or renewal of licences.

(b) ACTION ON THE PART OF -

I. STATE LICENSING AUTHORITY (SLA):
On the basis of statement contained in the application form and its varification/scruitinization thereof, SLA shall cause the manufacturing and testing establishment to be inspected in accordance with provisions of rule 79, independently or jointly with CDSCO with or without an expert in the field, as deemed necessary, and on being satisfied that the applicant is in a position to fulfill the requirements as laid down in the said rules, he shall prepare a report to the effect and forward, along with his recommendation, the documents before issuing the licences to the applicant firm, for further approval by CLAA:

(i) 3 copies of the licences in form 28D in case of a fresh/new licence or 3 copies of the certificate of renewal on Form 26H, as the case may be, accompanied by 3 copies of the list of items proposed to be manufactured (each leaf to be signed and stamped) as well as copies of Report of inspection and verification of the compliance of the improvements made. It would be much desirable if SLA forwards separate sets of licences etc. in cases where the applicant firm is undertaking manufacture of both LVPs and Sera & Vaccines.

(ii) If the SLA is not satisfied, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence as the case may be.

(iii) SLA may also keep the Zonal Officer of CDSCO informed on the final action taken on the application received by them and its disposal thereof.

II. ZONAL/SUB-ZONAL OFFICER OF CDSCO:

1. As the concerned Zonal/Sub-Zonal officers are the pivotal coordination wings of CLAA, he may, on receipt of application and its scrutiny thereof, contact SLA in assisting for quick disposal of the case by proposing further action (like joint inspection etc.)

2. To take up the matter with the applicant firm in case the application is considered deficient in terms of plant, equipments etc.

3. To keep the CLAA informed on the proposed action/inspection carried out etc. by forwarding recommendations on the observations made of the inspection carried out of the applicant firm.

III. CENTRAL LICENCE APPROVING AUTHORITY :

1. On receipt of the copy of the application, he may on his own take up the matter with SLA and Zonal Officer to initiate steps for quick disposal of the case.

2. After scrutinizing the documents sent by the SLA/Zonal Officer, he may, if so required, carry out further inspection or seek necessary clarification from SLA/Zonal Officer/applicant firm before approving the grant or renewal of the licences.

3. Out of the 3 sets received, 2 sets of copies of the licences, list of items proposed to be manufactures, shall be returned to SLA for issue of licence to the applicant firm under SLA's authority.

4. While returning the licences, the concerned Zonal Officer shall also be intimated about the final action taken on the application received by each of them.

Note : For grant of additional items proposed to be manufactured on their licences, the firm shall have to follow the above procedure for applying to SLA and/or approval by CLAA.

3. IMPLICATION OF NEW LEGISLATION :

1. The applicant firm shall ensure that the licences, granted or renewed (after the date of validity) by the SLA on Form 28D/26H, are statutorily required to be approved by the CLAA as otherwise the licences shall be deemed to be legally untenable within the provisions of Drugs and Cosmetics Act, 1940 and Rules thereunder.

2. The licences of LVPs/Sera & Vaccines must be on proper forms viz 28D for new/fresh licences and 26H for certificate of renewal.

3. It would be in the interest of applicant firm to get its certificates (licences) renewed by further approval of CLAA during the currency period.

1. I/We…………………………………...…….of……………………….…. hereby apply for the grant/renewal of a licence to manufacture for sale or distribution on the premises situated at …………………………………… the undermentioned Large Volume Parenterals/Sera and Vaccines, specified in Schedules C and C(1) to the Drugs and Cosmetics Rules, 1945.

2. Name(s) of drug(s)……………………………………………………………………………………………………………
(each item to be separately specified).

3. The name(s), qualifications and experience of the competent technical staff responsible for the manufacture and testing of the above mentioned drugs:

4. The premises and plant are ready for inspection/will be ready for inspection on……………………………………………

5. A fee of rupees…………………………….…. and an inspection fee of rupees…………………………has been credited to the Government under the Head of Account……………………………..

Notes : 1. The application is to be accompanied by a plan of the premises, list of equipments and machinery to be employed for manufacture and testing, memorandum of association/constitution of the firm, copies of qualification and experience of competent technical staff and documents relating to ownership or tenancy of the premises.

2. A copy of the application together with relevant enclosures shall be sent to Central Licence Approving Authority and concerned Zonal/Sub-Zonal officers of Central Drugs Standard Control Organisation.

FORM 28-D
[See Rule 76]
Licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines specified in Schedules C and C(1) excluding those specified in Schedule X

Number of licence………………………………………………… and Date of issue………………………………

1. ……………………………………………………………………… is hereby licensed to manufacture at the premises situated at…………………………………….. the following Large Volume Parenterals/Sera and Vaccines specified in Schedules C and C (1) excluding those specified in Schedule X to the Drugs and Cosmetics Rules, 1945.

2. Name(s) of drug(s)……………………………………………………………………………………………………………
(each item to be separately specified).

3. Name(s) of competent technical staff

4. The licence authorise & the sale by way of wholesale dealing and storage for sale by the licensee of the drugs manufactured under the licence, subject to the conditions applicable to licence for sale.

5. The licence shall be in force from………………………. to …...……………

6. The licence shall be subject to the conditions stated below and to such other conditions as shall be specified in the rules for the time being in force under the Drugs and Cosmetics Act, 1940.

1. The licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, 1940.

2. If the licensee wishes to undertake during the currency of the licence to manufacture any drug specified in Schedules C and/or C(I) excluding those specified in Schedule X not included above, he should apply to the Licensing Authority and/or Central Licence Approving Authority for the necessary endorsement as provided in the Rules. This licence shall be deemed to extend to the items so endorsed.

3. Any change in the competent technical staff named in the licence shall be forthwith reported to the Licensing Authority and/or Central Licence Approving Authority.

4. The Licensee shall inform the Licensing Authority and/or Central Licence Approving Authority 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 applied for alongwith prescribed fee and necessary documents to the Licensing Authority and/or Central Licence Approving Authority in the name of the firm with the changed constitution.

FORM 26-H
[See Rules 68-A, 76, 77, 78]
Certificate of renewal of licence to manufacture for sale of Large Volume Parenterals/Sera and Vaccines specified in Schedules C and C(1) excluding those specified in Schdule X.

1. Certified that licence No…………………………………….. granted on the……………………………………… to ……………………………… for the manufacture of following Large Volume Parenterals/Sera and Vaccines at the premises situated at………………………. has been renewed from……………………………. to………………………….

2. Name(s) of drug(s)……………………………………………………………………………………………………………
(each item to be separately specified).

3. Names(s) of competent technical staff: