Karnataka's four private drugs testing labs for Ayush drugs have been approved by the Department of Ayush, as private labs that could be accessed by drug manufacturers to test samples prior to the approval from the state drug licensing authority.
The four labs are among the 16 testing labs in the country approved under Rule 160-A of the Drugs and Cosmetics Act to test ayurveda, unani and siddha drugs. The licensing authority will have to pick up one or two samples at random and get them tested in the approved labs. To meet the expenses, a sum of Rs 500 per sample has been sanctioned. The authorities will have to submit the expenses voucher along with ten current test reports.
The four labs from Karnataka are Bangalore Test House, Foundation for Revitalization of Local Health Tradition (FRLHT), Shriram Institute of Industrial Research and MS Ramaiah Drugs and Allied Products Testing Laboratories.
The remaining private labs which are now recognized for under taking the quality assessment are Varun Herbals, Hyderabad, Sipra Labs, Hyderabad, Captain Srinivas Murti Drug Testing Lab Institute CCRAS, Chennai, Saribarinka Herbal Extract, Chennai, Regional Research Laboratory, Jammu, ARBRO Pharmaceuticals, New Delhi, Ozone Pharmaceuticals Haryana, Standard Research Lab, Indore, Anusudhahan Analyticals and Biochemical Research Lab, Indore, Choksi Labs Indore, Quality Control Lab, Bhopal and JRD Tata Foundation for Research in Ayurveda and Yog Services, Satna in Madhya Pradesh.
The decision to identify and select the private labs to test all the ayurveda, unani and siddha drugs came about after a Union government notification 'DO. No. K-11025/1/2006 DCC/Ayush' called for testing of survey samples of ayurveda, siddha, unani, homeopathy drugs by government approved centres or NABL accredited labs, said Dr, KM Nanjappa, deputy director, (Pharmacy), Government Central Pharmacy and the Drug Licensing Authority in the State
The circular from the Department of Ayush, government of India stated that quality control of Ayush drugs was the statutory responsibility of the State licensing authorities. To inspect the manufacturing units and collect survey samples for testing the quality of the drugs.
Although the Drugs & Cosmetics Act states that samples for legal action could be only tested in the government state drug test labs or designated laboratories notified for the purpose, in the case of survey samples can be assessed in any approved lab. The infrastructure of the government labs is not fully functional. Though government of India has provided the funds to upgrade the machinery building, equipment and recruitment of contractual manpower, the government drug test labs are still not ready.
Till these labs get ready, it is the responsibility of the state licensing authority to make arrangement to pick up the survey samples and get them tested at an accredited lab either in the State government approved lab under Rule 160 A or NABL accredited facility. This will cultivate a quality culture as the manufacturers will have to follow proper standard operating procedures(SOPs) to meet the requirements of the survey samples testing by the licensing authorities, stated Dr Nanjappa.