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Tuesday, April 6, 2010

Prevent substandard ISM drugs

People in Tamil Nadu scout for extension of inspections on ISM productsTuesday, April 06, 2010 08:00 IST Peethaambaran Kunnathoor, ChennaiEven as the investigation into the re-cycling issue of time-barred allopathic drugs in Tamil Nadu has been handed over to the state CBCID, there is a growing feeling among the people that such inspections should be extended on the Indian System of Medicines (ISM) also, as it may unearth illicit trade practices prevailing in the sector.The stern measures taken by the Chennai Police along with the drug control officials have not only unearthed huge quantum of hidden expired drugs from the godowns of drugs mafia, but also helped to expose the truth that the medicine market was hitherto controlled by a gang of drug racketeers. When a small percent of this mafia’s business could be disclosed by the Chennai police, it is hoped that the initiatives of police might help to filter and purify the drug market in the state. According to ISM industry people, such measures by regulatory and investigation agencies are called for in the herbal medicine market to purify and streamline the state’s own traditional healing system.Tamil Nadu has a unique reputation in the making and selling of herbal drugs, especially Siddha medicines whose credit has gone past the seas. The ISM division functions under a separate department which extends all its possible help for the growth of the industry, though it faces so many regulatory challenges. Unlike the allopathic pharma industry, the traditional medicine industry in the state lacks a strong organizational set-up in manufacturing and trade levels. The application of regulatory norms is less compared to that of the allopathic drug industry taking the advantage of century old history which often helps the units keep away from implementing the strictures of Ayush departments.According to sources, in Tamil Nadu, only 60 ISM manufacturing units have obtained GMP status and about 400 units are continuing operations without securing GMP certification. Many of the herbs prescribed in texts for making particular drugs are not available or unaffordable. For example, ‘Nilavembu Kudineer’ is a popular Siddha drug for viral fever. The main ingredient for the medicine is Sandal wood. Since the cost of Sandalwood is increasingly high, not all the small scale manufacturers can afford to buy it. There are reported cases of spurious and adulterated drugs in the ISM industry, but cases under Drugs & Magic Remedies Act initiated against any company by regulatory authorities are few. Big companies are expending huge amount for advertisement in print and electronic media for marketing their products which are, as per D&C Act, violation of the law.A recent incident shows the fact that strict regulation is necessary in the ISM sector also. In the year 2008, some researchers in the Boston University School of Medicine had found that one fifth of ayurvedic medicines made in the US and India, and sold in various parts America through online business were found to contain more than permissible levels of toxic metals. The study of the research fellows, which was an extension of an earlier study conducted in 2004, was published by an American Medical Journal. So to establish the authenticity and integrity of the Indian medicines, it is the duty of the government to monitor each phase of manufacturing by ensuring that the units are strictly following the GMP norms.In Chennai alone, the number of retail pharmacies selling ISM medicines has exceeded 150, and in the whole state there are more than 1500 pharmacy shops. The herbal scientist and the secretary of the Centre for Traditional Medicines and Research, Dr Thirunarayanan said many of these shops are selling herbo-mineral drugs without proper medical prescriptions. Even many consumers of these drugs are not aware of the shelf life of the medicines. The Department of Ayush has made it clear that every drug should have a shelf life and the expiry and manufacturing dates should be mentioned on the label of the medicines. This is the time the ISM drug authorities need to be cautious and proactive to avoid large scale illicit trade practices, if any in the market, to avoid disrepute to Ayush products.

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