[india-drug] Re: Information on Indian vaccines quality (2)

["dicmspc" <dicmspc@hathway.com>]

To,
John Stanford

Please visit the website of Central Drugs Standard Control Organization,
Dte.GHS, Ministry of Health and Family Welfare, Government of India
Central Drugs Standard Control Organisation and the state licensing
authorities issue various licenses for import, manufacture, sale and testing
of drugs and cosmetics. Besides, CDSCO issues some certifications eg. GMP
Certification as per WHO norms. The links from this page lead you to the
information about the various licenses and certifications and gives guidance
about obtaining them.
Please visit the link: http://www.cdsco.nic.in/html/seravacci.html

Also on http://www.cdsco.nic.in/html/vaccines2006.html you will get all
vaccines registered in the year 2006.

The regulatory control on quality of Indian made vaccines comes clearly in
Drugs and Cosmetics Rules, 1945
1[SCHEDULE F(I) PART 1-VACCINES
(A) PROVISIONS APPLICABLE TO THE PRODUCION OF BACTERIAL VACCINES:
1. Definition. -(1) This part of the Schedule applies to bacterial vaccines
made from any micro-organism pathogenic to man or other animal and to vaccines made from other micro-organisms which have any antigenic value.
(2) For the purposes of this part of the Schedule, a bacterial vaccine means
a sterile suspension of a killed culture of the micro-organism from which the vaccine derives its name or a sterile extract or derivative of a micro-organism, or a pure suspension of living microorganisms which have been previously made avirulent.
2. Staff of Establishment.-A competent expert in bacteriology with
sufficient experience in the manufacture and standardisation of biological products shall be in charge of the establishment responsible for the production of bacterial vaccine and he shall be assisted by a staff adequate for carrying out the tests required during the preparation and
standardisation of the vaccines.
3. Proper Name.-The proper name of any vaccine shall be the name of the
microorganism from which it is made followed by the word "Vaccine" unless this Schedule otherwise provides or if there is no other special provision in this Schedule, some other name as approved by the Licensing Authority. Provided that in the case of the undermentioned preparations the proper name of the vaccine may be as follows: -
1. Anthrax Spore Vaccine (Living).
2. Blackquarter Vaccine.
3. Enterotoxaemia Vaccine.
4. Fowl Cholera Vaccine.
5. Haemorrhagic Septicaemia Adjuvant Vaccine.
6. Haemorrhagic Septicaemia Vaccine (Broth).
2[7. Multi Component Clostridial Vaccine.
8. Hemorrhagic Septicaemia Vaccine - Alum Treated.]
4. Records.-Cultures used in the preparation of vaccine before being
manipulated into a vaccine, should be thoroughly tested for identity by the generally accepted tests applicable to the particular micro-organisms.
The permanent records which the licensee is required to keep shall include
amongst others, a record of the origin, properties and characteristics of the cultures.
5. Combined Vaccines.-Vaccines may be issued either singly or combined in
any proportion in the same container. In the case of combination of vaccines, a name for the combined vaccine may be submitted by the licensee to the Licensing Authority, and if approved, may be used as the proper name of the vaccine.

The soft copy of the Act is available on
http://www.cdsco.nic.in/html/Drugs&CosmeticAct.pdf (page number 301
onwards..)

. If you need more information in this area, please contact Drug Information
Centre immediately.

Regards,

Dr. (Mrs.) Sampada Patvardhan (Ph.D.Tech. Pharmacology)
Director, Maharashtra State Pharmacy Council's Drug Information Centre India
E.S.I.S. Hospital Compound, L.B.S. Marg, Mulund (W), Mumbai-400 080
Phone: 25930607  Telefax: 25684291/25684418
e-mail: dicmspc@yahoo.co.in  OR dicmspc@hathway.com