Karnataka Indian Medicine Manufacturers' Association (KIMMA) which was engaged in an interactive discussion with the State directorate of Ayush regulatory officials failed to arrive at a consensus about the approval of new products among other issues.
In a communiqué to Sadia Sultana (KAS cadre), in-charge controlling authority and Director, Karnataka directorate of Ayush via letter dated April 15, 2008, Ref. No. KIMMA:GC:239:2008 JSD Pani, president, KIMMA asserted that the Association disagrees to mention recommended dosage for proprietary medicines and procurement of Rasaushadhas (Bhasmas) for use in proprietary formulations from the GMP certified units without insisting for use of cow dung as fuel to produce the bhasmas.
Criticisms also came in for the failure by the State Directorate for not purchasing drugs under the allocated budget in 2007-08.
Objections were raised on insisting for clinical trials for most common formulations even though these were similar products licensed by the Karnataka and Central regulatory wing.
KIMMA also expressed its anguish about the directorate's inaction in constituting the technical expert committee to recommend the formulations of the proprietary ASU drugs for dispensaries and hospitals. Referring to the list of essential drugs issued by the Union government's Department of Ayush KIMMA has demanded a similar list of formulations of proprietary ASU drugs to avoid corruption.
The State directorate is likely to have another round of talks with KIMMA to sort out issues, failing which would refer the matter to Union government's Department of Ayush, informed Pani.
However, KIMMA conceded to accord instant approval to drugs already incensed by other state licensing authorities to be manufactured in Karnataka These included licensed proprietary and classical preparations with change in constitution, name change of manufacturer or proprietor.
License for part processing /manufacturing /packing under provisions of Sec 3 (f) of the Drugs & Cosmetics Act was agreed by KIMMA.
With regard to constitution of a technical committee under Rule 154(2) of the Drugs & Cosmetics Rules 1945, the State Directorate had agreed to the applicant manufacturer or representative to be present along with a KIMMA member to seek approval of new products. In this regard, it was also agreed that the technical committee would meet every month on a date notified in advance.
Referring to the menace of unlicensed products in the market, KIMMA assured total cooperation with the licensing authority and initiate legal action according to the Act. Drug inspectors have been directed to exercise powers under Section 33 H of the Act to check the sale of unlicensed ayurveda, siddha and unani (ASU) drugs. KIMMA will support the regulatory authority while taking action against the manufacturers for gross violation of GMP and licensing rules. The Association will train its members about GMP compliance. It has urged the regulatory authority to identify and initiate action against large units failing to adhere to GMP norms instead of targeting only the smaller units.
KIMMA also requested the State Directorate to remove the government analyst and government drug testing laboratory from the administrative control of Government Central Pharmacy to make it a legal entity to handle the testing of legal samples of ASU drugs.