Karnataka Indian System of Medicines Manufacturers' Association (KIMMA) has criticized the central government notification to amend the Drugs & Cosmetics Act 1940 which calls for centralized product registration and licensing with the Department of Ayush (Ayurveda, Unani Siddha and Homeopathy) drugs.

The draft notifications have already been published in Government of India (GoI) gazette dated October 18, 2006. GoI has invited comments from the industry before January 17, 2007. The notification is not only against the small-scale units but also against the federal fabric of our constitution, said JSD Pani, secretary, KIMMA.

Licensing authority is notified by the state government under Rule 152 of the D&C Rules 1945 where as controlling authority (Drug Controller) is notified under Rule 50 of the D&C Rules 1945. These two Law enforcing authorities have different powers and responsibilities. They are not one and the same, as many have understood, he said.

The first notification proposes to centralize the licensing of ISM drugs. Licensing of new drugs in modern medicine for those formulations already existing and is done at the state level. "There is no reason for the GoI to insist for Ayush drugs approval from the central authority. If GoI wanted a formal approval, it should provide clear guidelines to state authorities. It should also insist on maintaining a registry of approved products which should be submitted to the central authority," said Pani.

With regards to the second notification on raw materials, the KIMMA secretary informed that presently the licensee maintains the records of raw materials purchased, tested and used for production. The records are made available to drug inspectors during inspection. Now the submission of a periodical report to central authorities is a burden for the small-scale units whose suppliers are local vendors and utilization of raw materials is miniscule. The GoI should insist on raw material records of those units, which have an annual consumption of one tonne, he pointed out.

While KIMMA welcomed moves from the central and state governments for manufacture of quality drugs, this move was more relevant for large-scale manufacturers and is viewed as an impediment for the progress of the small units, he stated. From an industry perspective, the notification was appreciated and has been looked upon as a mandatory requirement for quality recognition.

"Himalaya has always followed stringent norms regarding labelling, quality, manufacturing, production and the like but there are several unorganised players in this market, causing concern to the industry as a whole. There is a need to have formal rules in place, which support a strong regulatory framework. We appreciate the efforts by the government to implement rules and regulations, which will lead to greater standardization within the Ayurvedic industry. This will have a positive impact on the industry, giving it a strong boost in both the domestic and international markets"- Dr S K Mitra, executive director - R&D, The Himalaya Drug Company told.