The Kerala Drug Control Administration (DCA) has formed a core committee to offer the requisite technical guidance for the SSI units in the state to comply with the fast approaching Schedule M deadline of December 31, 2004.

The core committee was formed based on the feedback and apprehensions on lack of technical knowledge and proper guidance hindering the modernisation process, aired by the manufacturers at a two-day workshop on cGMP and Schedule M organised last week jointly by the state drug control department and the Kerala Pharmaceutical Manufacturers Association (KPMA).

The two-member core committee on Schedule M implementation, comprising of M P George, assistant drug controller, Kerala and a senior KPMA office bearer nominated by the association, will soon start to visit the individual units for assessing the ongoing modernisation process. The committee will discuss with the individual unit owners on the areas which are to be modified or rectified and will be in regular touch with them to assess the progress of modernisation.

Talking to Pharmabiz, M P George noted that the committee could in effect act as a monitoring cell to assess the progress of Schedule M implementation. "The most interesting development of the workshop was the enthusiasm shown by the manufacturers to change, in accordance to the demands of the future. The workshop was a major breakthrough in sensitising the manufacturers here on the need for modernisation. They have realised that it is important to bring in the state of the art technology standards to stay in business, whether the present Schedule M deadline becomes a reality or get further extension," said George.

The sources said T P Gopinathan, drug controller, Kerala, inaugurated the workshop held at Hotel International, Kochi and attended by over 100 manufacturers and delegates from different parts of the state. In his address, the DC requested manufacturers to take full advantage of the deliberations of the workshop and try to mould their mind set up to comply with new Schedule M regulations and stand in line with the rest of the country.

Speakers at the seminar noted that the Indian drug industry has grown many fold in the last decade, mainly due to increase in domestic consumption and increase in exports due to the liberalised business environment. Though the people of Kerala are among the main consumers of drugs when compared to other states, the state manufacturers only about 10 per cent of the medicines consumed in the state. Out of the 90 odd licensed allopathic drug manufacturers in the state, only 50 are active, noted the speakers.

The inaugural function was presided over by Dr. A M D Namboodiri, president of KPMA. Dr A D Krishnan welcomed the gathering and M P George proposed vote of thanks. M Mithra of the Central Drugs Standards Control Organization (CDSCO), Ghaziabad, Prof Dr Saranjith Singh of NIPER, New Delhi, Manju Nath and Prashanth Raidu of Rinac India Ltd. etc. spearheaded the various sessions at the workshop, said sources.