Rs.2.47 crores, cGMP compliant, Director General of Health Services, ICMR, DCGI, Mycobacterium bovis, M bovis" /> Health ministry asks BCG Lab to withhold developmental works & address the issue of niacin positivity in seeds strain
 
 
 
 
 
       
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Health ministry asks BCG Lab to withhold developmental works & address the issue of niacin positivity in seeds strain

Peethaambaran Kunnathoor, Chennai
Tuesday, February 22, 2011, 08:00 Hrs  [IST]

The Union Health Ministry has asked the director of BCG Lab in Chennai to withhold the decision of purchasing equipment and other items for the renovation of manufacturing facility as per WHO-GMP norms, until a final decision about the fate of the unit is taken by the ministry, it is learnt.


Further, the director has been advised to address the problem of niacin positivity in the seeds strain to be used for making BCG vaccine.


With the instructions of the ministry, BCG Vaccine Laboratory in Chennai cannot go ahead either with production process or with cGMP modification work.


Soon after the revocation of licence suspension early last year, the ministry had released funds to the tune of Rs.2.47 crore to make the unit cGMP compliant. Following it, the director spent Rs.85 lakhs on renovation, and equipment worth Rs.83 lakhs have been purchased. Orders for some other equipment to the tune of Rs.1.65 crore have been placed with some agencies, but not yet acquired. According to sources, the BCG has taken this decision to ensure full supply of vaccine from this year onwards. But in a meeting chaired by the Director General of Health Services in New Delhi last month, the BCG director was told not to proceed with the decision of purchase of more equipment for the purpose of modification of labs.


Apart from this, the director was advised to understand the procedure laid down in ensuring that the seeds strain is declared niacin negative. The director has to address the problem of niacin positivity in the seeds strain, for this, the matter has to be taken up with ICMR and DCGI.


When contacted, some vaccine experts said that if the seeds strain is niacin positive, they cannot be used for making vaccine. Further, the niacin positive bacteria will affect the individuals who are working with it.


According to experts, BCG vaccine strain is an attenuated bacterium of ‘Mycobacterium bovis’ which produces TB in cattle. After the attenuation, the strain (M bovis) is used for vaccination against Tuberculosis in childhood. The M bovis is niacin positive and it becomes negative after attenuation. If the niacin is negative, it will not produce disease, but it can be used as vaccine strain.


If the information coming out of BCG is true, the unit cannot manufacture BCG vaccine now by using the seeds it keeps as the niacin is positive.


According to some reports, one private vaccine manufacturing company near Chennai got the seeds of BCG vaccine from the BCG VL some years ago. If BCG VL cannot produce vaccine from the seeds it has, then the private company also cannot produce the vaccine with the seeds.


This creates a situation wherein only a Pune-based private company can produce the BCG vaccine in the country now.

 

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