(MENAFN- Live Mint) New Delhi: The Central Drugs Standard Control Organization (CDSCO) plans to further tighten the screws this year on those making and selling spurious and substandard medicines, a widspread problem in India.
As part of the plan, in addition to the revised schedule M good manufacturing practices (GMP) compliance, the apex drug regulator will focus on risk-based inspection, increased monitoring and sampling, and extensive sensitization and enforcement.
The plan also involves directing all states and UTs to share spurious and substandard drugs data with the Centre.
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“The government is very serious about the quality of the drugs. This year we have planned to aggressively continue schedule M good manufacturing practices (GMP) compliance, RBI and more importantly, keeping close check on spurious drugs,” said an official aware of the matter requesting anonymity adding that there is a zero-tolerance policy towards counterfeit and substandard drugs in the market.
States participating actively
The official said that states and UTs have also started to participate actively in surveillance of spurious drugs.
“Furthermore, Schedule M GMP compliance has now been mandatory for the MSME drugs firms having turnover less than ₹250 crore starting first January. We will strictly ensure that these companies are following the rules in letter and spirit. Action will also be taken by for the non-complaint companies,” the official added.
The Drugs and Cosmetics Act, 1940 defines the quality of drugs. In case of spurious drugs, investigation is initiated by the licensing authorities under the relevant provisions of the ASct.
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Drugs that are 'not of standard quality' (NSQ) or spurious can cause treatment failure and adverse reactions, increase morbidity and mortality, and contribute to the development of drug resistance.
To address the problem, the union government last year made it mandatory for pharma firms to print the bar code or quick response code for the top 300 brands of drug formulations, as specified in Schedule H2.
Last week, the government bust an illicit trade in spurious drugs in Kolkata in a joint investigation with the state government.
Queries sent to the health ministry spokesperson remained unanswered till press time.
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