Regulator considers digital platform for drugmakers’ test reports | Today’s news
New Delhi: In an effort to increase safety and transparency, India’s drug regulator is looking to make pharmaceutical quality checks public. First, it plans to create a digital platform where consumers can access batch-level quality test reports on drugs released for sale by drug manufacturers, according to two officials and a Rajasthan government communication to the Central Drug Standards Control Organization (CDSCO).
The move would go beyond the current practice of only flagging drugs that have failed quality control through monthly substandard quality alerts. By publishing reports on routine batch tests, the proposed system would give consumers better insight into the quality of the drugs they use, marking another step towards greater transparency in India’s $60 billion pharmaceutical industry.
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The plan was discussed in the second week of September at a meeting chaired by the Drugs General of India (DCGI), on behalf of Rajasthan’s drug regulator, against the backdrop of the May incident at Kota Hospital in which five women died after being given fake oxytocin injections.
After the first meeting, the matter was recommended for further discussion, one of the officials said.
India has more than 3,000 pharmaceutical companies and 10,500 manufacturing plants that supply both the domestic market and global supply chains.
Push transparency
The plan is the regulator’s latest step towards transparency. As Mint previously reported, India’s top drug regulator also plans to release the results of inspections of pharmaceutical factories.
“The Commissioner of Food Safety and Drug Control, Government of Rajasthan has submitted a proposal regarding the publication of quality testing reports of drugs manufactured by pharmaceutical firms through a digital platform,” a government document said.
Under current drug laws, manufacturers can only release a product for sale after it has been tested either by themselves or through a regulator-approved laboratory. However, they are not yet required to share laboratory test results with intermediaries in the drug supply chain.
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“…There is no such provision in the law to retain the product test report at the C&FA/State Pharmacist level, nor any such provision requiring the manufacturer to forward the product test report to the carriers and carriers (C&FA)/State Pharmacist,” the document said.
“Suitable provision is proposed to be incorporated in the Drugs and Cosmetics Act, 1940 and its Rules, 1945 to create a digital platform on which drug quality testing reports carried out by manufacturers can be made publicly available to enable the general public to access the quality testing reports of the drugs they are using,” it said, thereby ensuring greater transparency regarding the quality of drugs.
“Information necessary”
In an official DCGI notice, the Rajasthan Drug Controller said that providing information to the general public about the quality of drugs is essential and quality testing reports conducted by manufacturers at their own level prior to launch must be made public.
However, industry experts said the move may not be practical.
“Practically, universal digital access is not possible. With manufacturers producing millions of batches and over 8 lakh retail chemists across India, making every record available to all consumers adds no serious value. Uday Bhaskar, former CEO of Pharmexcil, an industry body for exports in the sector.”
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“Instead of these unfeasible plans, the authorities should start focusing on ‘substandard’ products. Rather than just uploading them on a website, this important information must be communicated immediately to every retailer, wholesaler and consumer, with the support of an effective drug recall mechanism. Safety from digital platforms must be a priority, which can be implemented,” said Bhaskar.
Queries emailed to the spokesperson of the Department of Health and Family Welfare, the DCGI office and the Rajasthan Drug Controller remained unanswered till press time.
