The Hindu Business Line : Bengal in CAG line of fire over drugs Act

THE Comptroller and Auditor General of India (CAGI) has remarked that the implementation of the Drugs and Cosmetics Act, 1940, was "unsatisfactory" in West Bengal during 1998 to 2003.

It said consumers had been prone to serious health hazards due to inadequate sampling, inordinate delay in testing, failure to seize Not of Standard Quality (NSQ) drugs and impose penalties against spurious drug manufacturers and lack of monitoring and supervision.

The recently published CAGI report, for the year ended March 2003, has stated that the shortfall in sampling drugs in the test-checked ranged between 48 and 92 per cent during 1998-2003. Against the required inspection of 0.92 lakh licensed establishments, only 4,324 (5 per cent) were inspected by district officers; only 27 raids were conducted during 2000-2002 while no raids were conducted at all during 1998-2000.

Of 378 complaints received during November 1999 to December 2003, action against 66 cases and enquiry reports for 82 cases were awaited as of March 2003. In three test-checked districts, a total of 104 pharmacists were engaged in more than one shop, contravening the requirement of a one whole-time pharmacist per shop.

The State's Directorate of Drug Control had not taken any action against 99 firms producing NSQ medicines, facilitating unabated production of such drugs. The Drugs (Price Control) Order, 1995, was not implemented in the State prior to 2002, while there was no mechanism to check overpricing of drugs in the district offices test-checked.

There was delay of more than a year in sending test reports on NSQ drugs. Forty test reports, including 25 NSQ reports, were issued after the date of expiry of the tested medicines. NSQ drugs, valuing about Rs 79 lakh, had been consumed in the absence of a effective monitoring system. The Central Medical Store in the city returned Rs 29-lakh drugs that were found NSQ after tests to 41 suppliers during 1998-2003, but the Directorate of Drug Control neither seized those drugs nor initiated any penal measures against the suppliers.

It was mentioned that several incidents of toxicity and death occurred in government-managed hospitals after administering NSQ drugs. In fact, no action for wide publicity of the 69 categories of drugs banned by the Union government was taken to ensure non-marketing and consumption of those drugs.

In the given scenario, CAGI has recommended that the State government amend its rules to ensure that none of the manufacturing and selling units continue to transact business without renewing their licences by prescribing a time limit for renewal and completion of renewal formalities before date of expiry. It has also suggested that special courts/ tribunals be created for prompt and timely disposal of prosecution cases against the manufacturers/sellers of spurious and sub-standard drugs.

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