THE 60-year-old BCG Vaccine Laboratory in Chennai has stopped production of the anti-tuberculosis Bacillus Calmette-Guerin vaccine since January, following the suspension of the manufacturing licence issued to it by the Drugs Controller General of India on January 16.
The order suspending the licence till such time new facilities are made ready is based on the Assessment Report submitted by World Health Organisation (WHO) experts after an inspection of the laboratory in October 2006. The inspection, conducted under the direction of the Directorate General of Health Services (DGHS), was part of an exercise to assess compliance with current good manufacturing practices (cGMP), for upgrading the plant to WHO-recommended protocols. The Director of the laboratory, Dr. N. Elangeswaran, has prepared an appeal against the suspension order to the Union Health Secretary. In the appeal, dated January 24, Elangeswaran said: The licence for manufacture of vaccine or any pharmaceuticals shall normally be issued by the Licensing Authority on the basis of scientific evaluation of (1) safety, (2) efficacy, (3) quality and (4) supply of the medicines or on receiving any adverse report on the above issues. Further, no Adverse Effect Following Immunisation has been received over many years, which clearly indicates that the vaccine manufactured at BCG Vaccine Laboratory is safe.
He said his office had taken measures to rectify the deficiencies highlighted by the inspecting authority and referred to his earlier letters to the Health Department seeking six months to one year to complete the rectification process. In view of this, he requested that the suspension order be revoked. The laboratory is the sole contributor of BCG vaccines to the Central governments Expanded Programme of Immunisation (EPI). Seen in the background of the success and impact of the immunisation programmes, the role played by the Chennai laboratory in controlling the spread of tuberculosis, particularly in respect of childhood TB and tuberculosis meningitis in children, is commendable.
The laboratory, established in 1948, has an installed capacity of 80 million doses of vaccine a year. A subordinate office under the DGHS, the laboratory initially produced liquid BCG vaccine and Tuberculins with the help of the Statens Serum Institute, Copenhagen, Denmark, through the WHO. The strain used for the vaccine was DANISH1331. As the liquid BCG vaccine was found to have a short shelf-life, the laboratory started manufacturing freeze-dried vaccine. When difficulties arose in obtaining the Danish seed, the factory started to make its own lot.
At the time of suspension of production, the laboratory was engaged in producing freeze-dried BCG vaccine (20 doses) for the control of childhood TB and TB meningitis in children, and to meet the needs of the EPI; freeze-dried BCG therapeutic vaccine (40 mg) for cancer chemotherapy, particularly carcinoma of urinary bladder; and purified protein derivative RT-23 (Mantoux reagent) for diagnosis. It also served as the National Quality Control Laboratory for the BCG vaccine, and provided training facilities.
Given that the laboratory has been meeting the entire BCG vaccine needs of the country, the stoppage of production could throw the immunisation programme out of gear. The shortcomings found by the WHO team cannot be ignored, though.
The experts report observed that the laboratory was short-staffed and that not all the posts had been filled up, putting additional burden on the existing staff. It suggested extensive training for the existing staff. Instead of thinking in terms of GMP and the Drugs and Cosmetics Act and Rules as far as working is concerned, the staff think more on the lines of gazetted and non-gazetted posts nomenclature. For instance, the Director, though not authorised to release products, does so as the other competent staff are non-gazetted. This mindset has to be changed. Another significant observation made in the report is that the Director [of the laboratory] is also the Director of Pasteur Institute, Coonoor, and cannot do full-time justice to the operation of this institute.
The plant will be able to operate to its capacity of 80 million doses a year without any overtime if the balance 47 posts are filled up, the report said, adding that the capacity could be enhanced if the plant was modernised. It also stated that most of the aspects related to the plant premises did not conform to GMP requirements and suggested that it would be prudent to redesign the whole facility or build a new one at another site conforming to WHO standards. This suggestion perhaps merits serious consideration.
The general secretary of the Confederation of Central Government Employees and Workers, Tamil Nadu unit, M. Duraipandian, told Frontline that the federation would oppose any move to close the three public sector undertakings. Even the WHO has not recommended closure of the units, he said.S. Viswanathan