The refurbished BCG Vaccine Laboratory in Chennai, which was defunct for the last five years, has now begun re-supply of vaccine for universal immunisation programme (UIP) of the country after resumption of production in February last year.
BCG VL was one of the three closed government vaccine manufacturing companies citing non-compliance of WHO’s GMP standards, in 2008.
According to Dr H G Bramhne, director of the Lab, the unit has supplied 81 lakh doses of vaccine from July to December in 2013, and the last despatch was 60,000 doses to the government of Bihar one month ago. Now a quantity of 36 lakh doses is remaining with the unit and it is under testing.
The resumption of supply was carried out without any publicity or inviting media attention as the vaccine was manufactured in the old lab after rectifying the anomalies found in the inspections. The construction of the new laboratory building is going on in the premises. It will be fully equipped with state of the art machines and will be handed over to BCG VL for operation in next June. Further, a period of six months will be needed for calibration and validation.
On commissioning of the modern Lab, a quantity of 800 lakh doses of vaccine can be manufactured in the facility per year. Bramhne said he hopes to commence the production in the new building next year. The building is constructed complying the norms of WHO. The production capacity of the existing lab is 400 lakh doses.
“We faced some problems in the old facility while resuming the production after a long period. Several of them were cleared, started the production and resumed supply to different states. The central agency for vaccine procurement gives us the list of places for supply and we despatch the product to those places. We will shortly send the last batches manufactured to central drug testing laboratory in Kasauli for final testing and approval”, the director said.
He said some of the objections raised by the inspectors during various previous inspections have been corrected and the process is going on. After taking over charge as director of the unit, he has changed the documentation and a new master formula was made. Batch Manufacturing Record (BMR), SOPs, and validation documentations were also made for whatever things purchased and validated. The company received assistances from agencies of Standardization Testing and Quality Certification (STQC) and Equipment Test Certification (ETC) for calibration and validation for which better techniques were applied.
According to him, 16 batches of vaccine are made at the existing facility at present. One batch will contain 1.2 lakh doses. The quantity will be increased to the level of 22 very soon. Before closure, BCG VL was supplying 400 lakh doses of vaccine, he said.
To a question, Bramhne said the total requirement of BCG vaccine for UIP in India is 900 lakh doses.