Drug controller to fortify whistle blower scheme

* Plans underway to beef up vigilance measures for pharma sector

Written by Anil Sasi | New Delhi | Published:June 17, 2013 1:05 am

The drug controller’s office is working on a plan to beef up the current set of vigilance measures in the domestic pharma sector,including a fortified whistle blower scheme,at a time when an increasing number of high-profile Indian generics players and their local facilities are finding themselves under the scanner of the US Food and Drug Administration (USFDA).

The Central Drugs Standard Control Organisation (CDSCO),the Central authority for discharging functions assigned to the Union government under the Drugs and Cosmetics Act,is strengthening its whistle blower scheme to “motivate the public and provide information to the regulators on movement of spurious drugs”,a government official involved in the exercise said.

Apart from this,the organisation 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 organisation 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.

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 drugmaker. 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 analysed samples of pharmaceutical use gelatin and “found them to be contaminated with spore forming bacteria”.

“A number of these initiatives were in the pipeline even before the recent incidents (Ranbaxy pleading guilty and other USFDA alerts). But we plan to now increase the vigil in light of the developments so that the provisions of the Drugs and Cosmetics Act is adhered to,” an official said.

An official said that an e-governance system is underway 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 organisations.

QUALITY STRATEGY

* The CDSCO is strengthening its whistle blower scheme to motivate the public to report on the movement of spurious drugs

* The drug controller is also working towards setting up 20 mini drug testing labs at port offices to monitor quality of imported drugs

* In the next five years,the drug controller would also set up ‘India Country Offices’ in five countries to inspect foreign manufacturing facilities

* Steps are on to induct more staff by creating 1,195 new positions in the next seven years

* Eight new Central Drugs Testing Laboratories would be set up

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