CDSCO to strengthen whistle blower scheme

The Central Drugs Standard Control Organization (CDSCO) is planning to strengthen its whistle blower scheme to "motivate the public and provide information to the regulators on movement of spurious drugs”. 

Apart from this, the organization is working on plans to set up 20 mini drug testing labs at port offices of CDSCO to monitor quality of imported and exported drugs and is also looking at purchasing 20 mobile drug testing vans to monitor quality of drugs moving in the market.

With Indian drug firms under increasing scrutiny, CDSCO also has plans to set up 'India Country Offices' in five countries to inspect foreign manufacturing facilities and address other regulatory issues. Over the next seven years, the organization also plans to correspondingly beef up its manpower by creating 1,195 new posts within its ranks, including 64 experts and additional 4,300 personnel for new laboratories, mobile drug testing labs and setting up a training academy. 

On the problems currently faced by drug firms in the US, CDSCO is planning to monitor case documents of companies that are already under the USFDA scanner such as:  On May 13, Ranbaxy had pleaded guilty to charges related to drug safety and falsifying data for adulterated drugs produced at two of its facilities in Dewas and Paonta Sahib and agreed to pay $500 million, the biggest ever settlement by a generic drug maker. Shortly thereafter, the USFDA had banned import of generic drugs from Wockhardt's Aurangabad facility. 

Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, too announced on May 23 that it was recalling multiple lots of three of its drugs from the US market due to an "odd smell", according to USFDA notification. Around the time Wockhardt got its import alert, a similar USFDA warning was issued to a Gujarat unit of Sterling Biotech. Sterling Biotech had received an earlier alert in end-November 2012 when the USFDA collected and analyzed samples of pharmaceutical use gelatin and "found them to be contaminated with spore forming bacteria". 

Due to these incidents CDSCO will increase the vigil so that the provisions of the Drugs and Cosmetics Act are adhered to. An e-governance system will also be set up that would increase transparency along with credibility. Under this framework, all offices and laboratories of CDSCO and offices of state drugs controllers will be interlinked.  Eight new Central Drugs Testing Laboratories with a capacity to test around 8,000 samples a year by each laboratory and an upgradation of existing six laboratories is also in the pipeline.

Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the states, while the Central authorities are responsible for approval of new drugs, clinical trials, laying down the standards for drugs, control over the quality of imported drugs and coordination of the activities of state drug control organizations.