Even though production of vaccine is still uncertain in the labs of BCG VL Guindy and PII Coonoor, the drug control department of Tamil Nadu has, on some conditions, renewed the manufacturing licences of the two government vaccine manufacturing units in the state upto 2012, it is learnt.
The department has renewed the licences after a period of four years, the last renewal was done in March 2007.
Sources in the Pasteur Institute said the department has renewed the licences of both the units putting forward some conditions that all the deficiencies should be rectified before December 2012. Either of the units has so far not complied with the deficiencies cited in the order of suspension of licences dated 16.01.2008
The union health ministry suspended the units’ manufacturing licenses on 16.01.2008 and later revoked it in February 2010. However, the state authorities had not renewed the licenses till last month because of anomalies found during inspections carried out in the units on several times. Now with the licences in hand, before going into commercial production, the units have to fulfill all the conditions that were cited as reasons for the closure in 2008.
When asked if the units are unable to enter into commercial production, why the licences are required, M Rajendran, the director of drugs control department said the licenses have been renewed following the instructions of the union government. He said the union MoH had earlier revoked the suspension and naturally the state authorities have to renew it for the interest of the country.
It was primarily cited while suspending the licences three years ago that both the institutes failed to comply with conditions of licenses in respect of condition (a) (I) of Rule 78 in not maintaining adequate staff, adequate premises and plant as provided in the Drugs & Cosmetics Rules. Secondly, the units had not complied to the norms of good manufacturing practices laid down in part-I and part-I –A of Schedule-M of Drugs and Cosmetics Rules.
In an RTI reply to the former director of both the institutes, Dr N Elangeswaran, by their CPIOs it was stated that the licenses of the units were revoked by the central authorities on 11.2.2010 and on 26.2.2010, and the state drug control authorities renewed it in September this year up to 2012.
According to vaccine experts, even though the licences have been renewed, the units cannot go for production until the institutes rectify the anomalies cited as reasons for suspension by the Central License Approving Authority in 2008.The experts said both the units have to set right their Effluent Treatment Plants (ETPs) as per cGMP norms and environment clearance must be obtained from Ministry of Environment. As per law, the licences are given only after clearing these hurdles.
In December 2010, the Tamil Nadu Drugs Control Department had rejected the application for renewal of licence submitted by PII Coonoor for manufacture and supply of vaccines because of not rectifying the anomalies in the lab.
In February this year, the union health ministry asked the director of BCG Lab in Chennai to withhold renovation activities and advised to address the problem of niacin positivity in the seeds strain to be used for making BCG vaccine.
BCG VL had also approached several times to the state drug authorities for renewal of its manufacturing licences, but its application was being rejected each time.