Karnataka's Directorate of Indian Systems of Medicine has not renewed licences of more than 100 drug manufacturing units in the ISM sector; for not complying with Schedule T. Out of the 250 units in the State only seven companies - The Himalaya Drug Company, Natural Remedies, Om Pharmaceuticals in Bangalore, Charak Pharmaceuticals and Dhanvanthri Smasthan in Mysore, Amrut Pharmaceuticals in Belgaum and Swadeshi Pharmaceuticals in Mangalore are GMP complied.

"We have taken stringent steps to ensure GMP compliance by stopping licenses of companies that have come for renewal without Schedule T norms," said Dr B S Nataraj, director, Directorate Indian Systems of Medicine, and Homeopathy, government of Karnataka.

However, the industry sources admits that considering the current scenario in the state ISM sector, there may not be more than 55 units out of the total 251 units that will be able to comply with the GMP requirements.

In the meanwhile, the Karnataka Indian Medicine Manufacturing Association (KIMMA) has come out with a proposal for some of the units that can comply to GMP to offer their premises for contract manufacturing services to the small units that cannot afford GMP compliance.

Although the central government has come forward with financial assistance to purchase equipment and set up the infrastructure as prescribed in Schedule T, it is only for the medium sized units and not for the small-scale units in the country.

According to the ISM policy, there are 10 large Ayurveda units in the country with a turnover of Rs.50 crore and above. There are 25 medium-sized units with earnings between Rs. 5 to Rs. 50 crore, 965 small units with a turnover between Rs. 1 to 5 crore and 6,000 units with earnings pegged less than Rs. 1 crore.

There is absolutely no chance of the small and tiny units to go in for GMP compliance because many of them are undertaking production of drugs in their homes and do not even have a place assigned to manufacture, said R K Agarwal, president, KIMMA and chairman, Natural Remedies, who is concerned about the welfare of the these units who must at least be able to survive by offering their products to be produced through contract manufacturing.