The ambivalent and stepmotherly attitude of the union health ministry on the issue of upgradation of the BCG Lab in Chennai is creating confusion over the fate of the unit, whether it will remain a manufacturing unit or converted into a testing lab.

The prolonged issue has of late caught the attention of a Parliamentarian, T K Rengarajan, who made a visit to the unit two days ago to get a first hand information about the unit which has been hitting headlines for all the wrong reasons. Whether it should remain as a manufacturing unit or as a testing lab alone is the decision the ministry has to take immediately because the situation is very much confusing with regard to this unit, said the Parliamentarian who had earlier raised the issue of vaccine units in the Parliament.

Meanwhile, the normal processes including production of Bacillus Calmette-Guerin (BCG) vaccine against tuberculosis, renovation work for cGMP facilities, maintenance of existing facilities, and despatching of finished products to CDL Kasauli for testing are going on smoothly at the vaccine lab at Guindy in spite of a tepid attitude from the higher authorities in Delhi towards it.

According to some reliable sources, the office of the Drugs Control General of India (DCGI) is aggressively acting with the government to convert this unit into a testing lab for BCG vaccine. If the unit is made as a testing lab, the private vaccine companies can test their products in the laboratory of BCG, which means that the private sector units can benefit a great deal out of it, it is learnt.

During his visit to the BCG lab two days go, Rengarajan was given the impression that the DCGI office is not taking any pro-active step in upgrading the institute into a most modern manufacturing unit. The Rajya Sabha member was informed that the present DCGI, after a visit to the lab a few months ago, reported to the ministry that the existing structure of the BCG Lab could not be made cGMP compliant, and at the most it can be converted into a Central Drug Laboratory (CDL) for BCG vaccine under overall control of CDL Kasauli.

The DCGI has further stated that if the government wants to continue production in the unit, its present structures should be demolished first and in place a new one be constructed for manufacturing facility. His observation was based on certain inherent flaws in the existing facilities. But sources said if the unit is turned into a CDL, there will be a requirement of additional technical manpower, training of the existing staffs and a need to have a cGMP compliant animal house.

From the information gathered during the visit, the MP team got the impression that there was lack of concern or interest by the responsible officers to maintain the unit in tandem with Pasteur Institute and CRI Kasauli. Soon after the decision of the government to revoke suspension of licence in February last year, the DCGI had visited PII Coonoor and CRI Kasauli more than one time, consequently they got sufficient financial aid to renovate their units, and thereby they could resume production. But the team led by DCGI visited BCG Lab very late and submitted a negative report to the health ministry. Sources in the health ministry said that the DCGI has no interest in keeping the BCG VL as a manufacturing unit.

Rengarajan has assured the unit staff that he would take up the issue with the union health minister and also raise it in the upcoming Parliament session.

In the meeting held by DGHS on January 17 this year, the director general of health services had pointed out that the decision of union health ministry in February 2010 was not to demolish the existing structure, but use if for manufacturing of BCG vaccine and to make it cGMP compliant within 3 years. The meeting was attended by the director of BCG VL also. It emerged from the discussion that there should be a need for a clear cut decision from the ministry of health & family welfare whether to demolish the existing structure or to construct a new building, or to modify the existing facility as a CDL.

The parliament member has got information that in the high level committees, the higher officials are showing so much interest towards PII Coonoor and CRI Kasauli, but a stepmotherly attitude towards BCG Lab. It is learnt that government is supporting private manufacturing units in procuring vaccines for the national immunisation programme.