Himachal: Pharmaceutical investors hope to get expansion

Himachal Pradesh: With less than two months left to comply with the revised Schedule M of good manufacturing practice norms, pharmaceutical companies falling under the micro small and medium enterprises category are yet to get an extension in the deadline. Those failing to comply with the conditions by December 28 will face suspension of their licences or penalties, according to a notification issued by the Union ministry in December 2023. The revised norms will bring them at par with the World Health Organisation norms. Citing lack of funds as the upgrade requires a minimum investment of Rs 5 to 6 crore, the Himachal Drug Manufacturers Association (HDMA) is seeking three years for its implementation.

The need to upgrade manufacturing facilities was felt by the Union ministry to ensure compliance with global quality standards and avoid the hassles of international drug recalls, which are tarnishing the image of Indian pharmaceutical companies globally. In Himachal too, it has been observed that the names of some firms regularly appear in the monthly alerts issued by the Central Drugs Standard Control Organisation, raising questions over quality drug manufacturing. In the monthly drug alert issued for September, 11 out of 25 drug samples manufactured by Himachal’s drug firms were found to be of substandard quality. Revised Schedule M has been prepared to address the deficiencies in manufacturing by adopting improved standards. As per the revised norms, the manufacturing area is to be divided into eight zones or rooms for injections, where specific area is also earmarked for each section.

It was observed that despite space constraints, some firms were manufacturing multiple products like injections, tablets, liquids, etc., and this often led to quality issues. A delegation of Himachal Drug Manufacturers Association (HDMA) recently met Union Health and Family Welfare Minister JP Nadda. However, they are hopeful that the deadline will be extended beyond December 28. “HDMA has given a memorandum to Union Health Minister JP Nadda and we are hopeful that we will get an extension in the deadline to implement the conditions of the revised Schedule M,” HDMA president Dr Rajesh Gupta told the inquiry. He said the industry welcomes the move but they are only asking for time as it takes time to arrange crores of rupees for an MSME unit and upgrade it to a running unit.