Drugs failing quality tests are being blacklisted for a stipulated period in the State.
In fact, a total of 25 drugs have been blacklisted for reasons including sub-standard quality, since March this year. This is part of measures taken to ensure the quality of drugs supplied to the public through government hospitals in the State.
The Tamil Nadu Medical Services Corporation (TNMSC) has laid down standards and put in place a mechanism to test drug quality. It has blacklisted the 25 medications, mostly for a period of two years from 2013, for lacking in quality and efficacy. In fact, more than 30 drugs are in the blacklisted category since 2009.
“Samples are drawn from every batch of drugs supplied. The samples are de-coded and sent for quality tests to any of the empanelled laboratories. The parameters checked include the composition of the drug, disintegration/dissolution of the drugs in case of tablets and capsules, and sterility in the case of injections. Even labelling mistakes are taken seriously,” an official says.
In case the drug fails the quality test, the sample is sent to the government laboratory for reconfirmation. “Once confirmed, steps are taken for blacklisting the product. The supplier is asked to recall the stock and a penalty is levied. We issue a showcase notice to the supplier seeking an explanation,” he says.
The product is then blacklisted for two years and the supplier is not allowed to participate in the tender for that product. If five of their products fail the quality test, the firm is blacklisted.
Supply of adulterated and spurious drugs will result in blacklisting of the firms for five years, an official says.
The details of blacklisted drugs are published online. A number of pharmaceutical companies too are in the blacklisted category for supplying drugs of poor quality and misbranding.
Teams of officials are also deputed across the country to inspect factories of suppliers. TNMSC also receives feedback from deputy directors of health services to assess and improve their services.