Work for vaccine production started in 2 PSUs, BCG Lab in Chennai yet to get green signal

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Even as two of the three PSUs, CRI in Kasauli and PII in Coonoor, have run into action within two months of accepting the order of resumption of vaccine production from the Union Health Ministry on February 26 this year, the BCG Vaccine Lab in Chennai is still waiting for approval from authorities to commence operations, it is learnt.

When the Central Research Institute in Kasauli has already started supplying three types of vaccines and anti-sera, the PII is set to start production of DPT vaccines in the middle of next month. These two institutes had shut down in 2008 on quality concerns along with BCG Vaccine Lab.

Whereas, in the BCG Lab, no work of renovation or standardization of plant could be done so far, said its director Dr Usha Sworen Singh. According to her, the unit is pinning hopes on health ministry to go ahead with production.

Even after the production licenses were suspended in January 2008, the government had appointed directors to these three units in order to make the facilities operational keeping international standards & WHO norms, and strengthen the production process.

While hailing the initiatives taken by the Union Health Ministry now, the director of PII, Dr B Sekar said release of the first batch of DPT vaccines from the institute can be expected by the year end. Later on, it will move into the manufacture of tissue culture anti-rabies vaccines. With the production starting in May, PII will become the second PSU to resume function of the laboratory to produce essential vaccines for the country’s immunization programme.

In the case of CRI Kasauli, its director Dr K V Mani said, the institute has started supplying DTP vaccine, Yellow Fever Vaccine, Typhoid Vaccine and anti-sera in April this year. An important aspect of the institute is that it is the only unit in south-east Asia to produce the yellow fever vaccine.

While speaking to Pharmabiz, the BCG Lab director said, “We are waiting of the arrival of officials from the health ministry. We need the health secretary’s approval for starting production. The suspension has been revoked now but we cannot go ahead and start the production. We need money, man power and other requirements in the facilities. Before that the renovation and standardization work have to be done.”

The director lamented that her office had sent letters to the DGHS and to the health secretary with regard to the resumption of production, followed by so many reminders, but no result at all.

According to sources the primary concern of the Health Ministry is to take a decision on the stock of vaccines in the unit. The unit has kept 200 batches of BCG vaccine vials in its cold storage, which worth about Rs 3.6 crore. It was learnt that the small quantity of the vaccine from the cold storage it sent to the central drug laboratory at CRI for revalidation test was rejected by Kasauli lab due to its date expiry. One batch contains 36,000 vials and one vial includes 10 doses. The cost of one vial is Rs 50. If it is destroyed, the state exchequer will incur a loss of more than Rs 3.5 crore.

While interacting with Pharmabiz, Dr B Sekar of the Pasteur Institute said, “On February 26 this year, through a letter, we were asked to resume production with the facilities available at the unit. Following it, I sent a plan of action to the secretary of Health and DGHS. We need servicing of the machines as there was no production for the last two years, replacement of old ones, standardization of the plant, besides some civil work. Everything we had to update with the government. The attitude of the Ministry was very encouraging. It allotted Rs 16.2 crore for the unit’s upgradation for the year 2010-11.”

He said in previous periods the government was allotting only fewer amounts. The director said within three years, the PII will have a fully equipped GMP facility of international standards.

According to Dr Mani, the CRI is supplying seven million doses of DTP vaccines to various government hospitals in the country now, and it is waiting for consignees list for National Immunization Programme requisite.

Dr Mani said that the institute plans to export TT vaccine to some countries soon. “The new GMP facility in the unit for the production of DTP, TT and DT will be completed in November this year. For the new facility, the government has allotted Rs 50 crore,” he said.


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