Since the government has clarified not to extend the deadline for implementing revised Schedule M norms after 1st of January 2005, numerous SSI drug manufacturers in Kerala and Tamil Nadu, who were complacent so far expecting at least two year extension, has initiated modernization process to avert permanent closure after the deadline.
The pharmaceutical manufacturers associations in both Kerala and Tamil Nadu agree that most of the units were complacent so far, citing various reasons.
In Kerala, only five or six units out of 90-odd allopathic drug manufacturers have manufacturing facilities complying with the revised Schedule M norms. The firms that have Schedule M complainant manufacturing facilities include the beleaguered public sector drug maker Kerala State Drugs and Pharmaceuticals Ltd., Variety Pharmaceuticals, Kokkatt Pharma, Vaishali Pharmaceuticals etc. Since more than 95 per cent of the manufacturers in Kerala are mainly general hospital item manufacturers dependent alone on government hospitals and local supply, setting up world class manufacturing facilities have never been their priority, note sources.
"Most of our members lack awareness on the importance of complying with the norms. Therefore, the association is in the process of taking up necessary awareness campaigns to help these units comply with the revised Schedule M norms" according to Dr A M D Namboodiri, vice-president of the Federation of South Indian Pharmaceutical Manufacturers Association (FSPMA) and President of the Kerala Pharmaceutical Manufacturers Association (KPMA).
Interestingly, more than half of the decentralized drug makers in Kerala have not even bothered to join the association, note sources.
The situation is not much different in the adjacent state of Tamil Nadu, despite the efforts of an active Tamil Nadu Pharmaceutical Manufacturers Association. Tamil Nadu, which has a large concentration of SSI units with more than 750 to 800 formulation makers and another 400 to 500 in various segments, just 20-odd SSI units have adhered to the Revised Schedule M norms, according to a recent official estimation by the Mashelkar committee.
"The situation is changing. Now everyday I receive at least one or two call from our members to seek ways to mobilize finance and technical help to implement modernization. Their attitude has changed, and most of the manufacturers now realize the importance of adhering to the Schedule M norms," notes T S Jaishankar, Chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), and President of the Tamilnadu Pharmaceutical Manufacturers Association (TNPMA).
Some sources say at least 10 to 20 units alone in Chennai are in the process of modernizing their manufacturing premises. Most of the SSI formulation makers in Tamil Nadu are concentrated in and around Chennai, besides a few clusters in Aalathur, Salem, Coimbatore, Madurai etc. Though TN PMA had pushed forward the idea of Quality Circle System to help SSIs in a cluster to work together like a co-operative to modernize, the idea had not received much response from the members, noted sources.