Pharma units to meet Schedule-M deadline

Quality circles, FDCA help firms

A proactive Food and Drugs Control Administration (FDCA) and the formation of a co-operative of small pharmaceutical companies to help them upgrade facilities at their units have ensured that most of the small pharmaceutical companies will comply with the Schedule M guidelines of the Drugs and Cosmetics Act, the deadline for which is December 31, 2004.

After postponing implementation of the guidelines, the government had said it will no longer postpone its implementation. The pharmaceutical units that do not upgrade their systems will thus face closure after January 1, 2005.

Pharma units which have a World Health Organisation-Good Manufacturing Practices (WHO-GMP) certification automatically conform to the revised Schedule M guidelines. Smaller companies need to invest a huge amount before December 31 to meet the requirements.

"Most small-scale pharmaceutical units in Gujarat will conform to the revised Schedule M guidelines. The quality circle movement will largely be responsible for this. I do not think there will be more than 50 to 80 companies left out," said S P Adeshara, commissioner, FDCA, Gujarat.

"There are about 900 pharmaceutical units in Gujarat and only 100 of these are large and medium sized. With the quality circle movement and a very supportive FDCA, we hope that most of the small units will adhere to the guidelines," said Kamlesh Udani, outgoing chairman of the Gujarat state branch of the Indian Drug Manufacturers' Association (IDMA).

This is quite an achievement considering that more than 90 per cent of the small scale units had not invested any money in upgrading facilities.

Revised Schedule M guidelines require small and medium units to invest between Rs 40 lakh and Rs one crore in upgrading their air control and handling, quality control and water systems.

The guidelines require companies to maintain proper documentation.

Originally scheduled to come into force from January 1, 2003, implementation of the guidelines was postponed to December 2003 and again to December 2004.

There are around 800 SSI pharmaceutical units in the state, all of which are required to adhere to the guidelines. Less than ten per cent of the units had taken steps to meet the guidelines.