The Union Health Ministry has withdrawn the order issued by Drugs Controller General of India suspending the vaccine manufacturing licence of the century old Central Research Institute in Kasauli, it is learnt. This is the first case of withdrawing the suspension licence to public sector vaccine manufacturing unit served on January 15, 2008. The other two units are yet to get a nod from the Government.

The DCGI had issued the orders to the country’s 3 PSU vaccine manufacturing units asking them to stop the productions following reported non-compliance of WHO GMP norms by them. CRI was the main producer of DTP vaccines for the National Immunization Programme and also to the Government hospitals. Other two units are PII, Coonoor and BCG Vaccine Lab in Chennai.

With this, the Unit will take a reversal to its past glory from next week, said Dr KV Mani, director of CRI. Procedures to filling and supply of unexpired vaccines kept in the cold storage will be started with in two days. The vaccines will be filled in single dose vials and multi-dose vials of five doses, ten doses and twenty doses.

The withdrawal of suspension order has in effect given the company the permission to go ahead with its activities of production and supply of vaccines as was done previously.

“We will soon start our operations. Initially we are concentrating on finishing the task of filling and supply of stocked vaccines. As many as six types of vaccines worth Rs 20 crore are in our cold storage. They are all date unexpired and can be used for NI programs. About seven to eight million doses of DPT is the main bulk. We will supply them to Government hospitals also. We are now not thinking of any commercial business with the stock,” said Dr Mani.

Another senior scientist in the Unit said there is a long process to be accomplished before supply is organized. The technical activities include the shifting of vaccines from the cold storage to the filling area where many procedures are to be followed. Before filling is done all the vials have to be sterilized in the machines. Sealing, inspection and identity test will be completed after filling process. Afterwards the filled up vials will be sent to the National Control Authority (DCGI office) for final testing, which is done in the Central Drug Laboratory. On completing all the processes, the DCGI will release a certificate granting permission to supply, the scientist told Pharmabiz.

Central Research Institute’s cold storage has the bulk stock of 8 million doses of DPT group of vaccines, 43 million doses of TT vaccines, five lakh doses of DTP. Besides it stores five lakh doses of JE (Japanese Encephalitis) vaccines also.

Shortly the unit will send the products to the concerned government agencies for National Immunization program. In January this year, the health ministry had issued a notice to the unit to assess the usability and stock of the vaccines stored in its cold storage. Following the report submitted by CRI, the government has taken the new decision.

Regarding production of vaccines, the Director said, the unit has to construct modern GMP facilities as per the norms of WHO, which they will start soon.