Karnataka Department of Ayush has issued orders that all manufacturers have to produce the particulars of the annual quantity and source of collection of the raw materials used by them for manufacture of drugs and dispatch details of the same for further verification.

The Directorate will then test the samples to ascertain the purity and the quality of the herbs or other raw materials used in the production of ayurveda drugs.

The orders have come in after an official notification from the department of Ayush, government of India to control quality of drugs at the raw materials stage.

"This process will ensure the purity of herbs which is vital for its efficacy, Dr KM Nanjappa, deputy director, Pharmacy and licensing authority, Karnataka department of Ayush told Pharmabiz.

The central government has approved that 60 per cent of the drugs for the 600 ayurveda dispensaries, 52 unani and 42 homeopathy medical centres in Karnataka had to be produced from the Central Pharmacy in Bangalore and the remaining 40 per cent drugs to be procured through rate contract from private manufacturers.

In this connection, the Karnataka department of Ayush has now asked all the 152 Schedule T compliant ayurveda drug manufacturers to submit the details, which include quantity, and quality details.

The government is also insisting on maintaining the ratio of proprietary to classical drugs as 80:20 for the medical centres. "Therefore the need to maintain quality standards is demanding because only a handful of manufacturers maintain quality and quantitative standards in proprietary drugs and there is also the issue of patenting their formulas. In the case of classical drug production, manufacturers need to adhere to formulae stipulated by the Government of India Ayurvedic Formulary of India, Unani Formulary of India and the Ayurveda Pharmacopeias of India Volume I to V.

Further, the official orders from the Karnataka department of Ayush has also called to provide a list of the qualified personnel employed in the manufacturing units as part of the human resources audit only to ensure that quality standards has permeated across all cadres.

According to Dr Nanjappa, although the state is known to have achieved cent percent Schedule T compliance at its 152 units and 129 loan licensees there are still discrepancies noted with regards to compliance of good manufacturing practices among the small units.

Some of the discrepancies include not obtaining prior permission of the licensing authority for renovation of units with no submission of any plans and alterations made to them by the licensing authority. There are also cases of manufacturers who do not provide the details of the products manufactured from the loan licensee while seeking licenses. Other issues are the lack of analytical test records maintained, fixing own in-house standards of raw drugs and not analysing finished products. The deputy director, pharmacy in his role as licensing authority has now intimated to the manufacturers to rectify and adhere to the rules in a stringent manner failing which action would be taken.