New Delhi: The pharmaceutical regulators will soon get more teeth to deal with poor-quality medications that are manufactured and marketed in India. A government proposal to revise the guidelines for taking action on producers of ‘not of standard quality’ (NSQ) drugs has been approved by the Drug Technical Advisory Board, the country’s top pharmaceutical advisory body.
As per the proposal under consideration, NSQ drugs that don’t fall under Section 27(a), 27(b), 27(c) of the Drugs and Cosmetics (D&C) Act of 1940 would be dealt with separately by having provisions for imposition of fine and other punitive measures. The modified guidelines would be incorporated in the D&C Rules of 1945 as Schedule K1.
The D&C (Amendment) Act passed by the Parliament in 2008 provides deterrent penalties for offences relating to manufacture of adulterated drugs which have serious implications on public health. The penalty has been enhanced to imprisonment for 10 years along with hefty fines. In certain cases, offences have been made cognisable and non-bailable.
The Drug Consultative Committee (DCC) guidelines currently followed by state drugs controllers categorise product defects depending upon their gravity. The poor-quality drugs are classified into three groups — spurious and adulterated drugs, grossly sub-standard drugs and medicines with minor defects. However, the existing norms are not part of the D&C Rules and their implementation varies from state to state. The rules are being modified to bring more clarity for uniform implementation, say official sources.
Though the guidelines instruct state drug authorities to resolve minor variations in quality by licensed firms through administrative measures, industry sources often complain of bureaucratic harassment. In the absence of a proper definition of NSQ drugs in the D&C Act, misinterpretation of spurious drugs lands many genuine producers in trouble, they say.
Furthermore, manufacturers are concerned about a new clause to slap fine on the drug maker and scrap the whole batch if a single unit is found to be defective. “Manufacturing is a continuous process and human or mechanical error is possible during final packing. An error of a single unit should not invite problem for the entire batch,” Sanjiv Rai, president of Bihar Drugs and Pharmaceutical Manufacturers’ Association, told Pharmabiz.
Experts stress that low quality of drugs cannot be blamed solely on manufacturers. Improper methods of testing and inadequate storage facilities at institutional level can also play spoilsport.
The government’s steps to crack down on substandard medications gain significance. According to National Drug Survey Report 2016, around 3-4 per cent drugs from market and 9-10 per cent from hospitals are of low quality. “This could be due to poor logistics. For instance, drugs from Baddi in Himachal Pradesh are transported to entire India by road or rail in normal conditions. Average temperature in India hovers around 30-35 degrees,” Dr Selvaraj, former Director of Drugs Control, Tamil Nadu, opined.