The Drugs Technical Advisory Board (DTAB) has turned down the Union health ministry's proposal to amend Rule 3-A of the Drugs & Cosmetics Rules, 1945 to declare the National Institute of Biologicals (NIB) as Central Drug Laboratory for testing of some of the vaccines such as BCG vaccine. These are currently being tested at Central Drug Laboratory, CRI, Kasauli.
Rules 3-A of the Drugs and Cosmetics Rules prescribes the functions which a laboratory may discharge as Central Drugs Laboratory in respect of the drugs specified therein.
The NIB, Noida is a notified lab under sub-rule (8) of Rule 3-A for testing of certain categories of drugs as appellate laboratory. These drugs include blood grouping reagents; diagnostic kits for human immunodeficiency virus, hepatitis B surface antigen and hepatitis C virus; blood products; and recombinant products such as biochemical kits.
According to sources, the issue of declaring the National Institute of Biologicals as Central Drug Laboratory for testing of vaccines such as BCG vaccine; live attenuated measles vaccine; live attenuated rubella vaccine; and cell culture rabies vaccines came up for discussion during the DTAB's 70th meeting held on August 18, 2015 at CDSCO Bhawan, New Delhi. At present, these vaccines are being tested at CDL, CRI, Kasauli. After detailed deliberations, the DTAB did not agree to the proposed amendment.
DTAB is the highest authority under the Union health ministry on technical matters which was reconstituted by the health ministry under section 5 of the Drugs and Cosmetics Act in February this year. Dr Jagdish Prasad, director general of health services, is the chairman of the newly formed DTAB. Dr G N Singh, Drugs Controller General (India), is the member secretary of the Board.
C Hariharan, director in-charge, Central Drugs Laboratory, Kolkata; Dr. A. K. Tehlan, director, Central Research Institute, Kasauli (HP); Dr G. B. Gupta, vice chancellor, Chhattisgarh Ayush and Health Science University, Raipur; Sudhir Mehta, chairman, Torrent Pharmaceuticals Ltd, Ahmedabad; Dr B Suresh, president, Pharmacy Council of India (PCI); Dr Nilima Kshirasagar, chair in clinical pharmacology, ICMR; O. S. Sadhawani, controlling authority & joint commissioner, FDA Mumbai: Dr H G Koshia, commissioner, FDCA, Gujarat; Dr. Madhu Dixit, Central Drugs Research Institute, Lucknow; Dr Rao V S V Vadlamudi, Hyderabad; Dr. P. Dhar, principal scientist, Indian Veterinary Research Institute, Izatnagar; Prof. M. D. Karvekar, Bengaluru; Dr. Muzaffar Ahmad, Rep., Medical Council of India; Dr. A. Marthanda Pillai, Ananthapuri Hospital and Res. Institute, Thiruvananthapuram; and Sheju Purushothaman, government analyst, RDTL, Kerala are the other members of the DTAB.