Regulator mulls digital platform for drugmakers' test reports

New Delhi: In a push for higher safety and transparency, India’s drug regulator is looking to bring pharmaceutical quality checks into public view. In a first, it plans to create a digital platform where consumers can access batch-level quality-test reports of medicines released for sale by drugmakers, according to two officials and a Rajasthan government communication to the Central Drugs Standard Control Organisation (CDSCO).

The move would go beyond the current practice of only flagging drugs that fail quality checks through monthly not-of-standard-quality alerts. By putting routine batch-test reports in the public domain, the proposed system would give consumers greater visibility into the quality of medicines they use, marking another step towards greater transparency in India’s $60-billion pharmaceutical industry.

The plan was discussed in the second week of September at a meeting chaired by the Drugs Controller General of India (DCGI), on a representation by the Rajasthan’s drug regulator in the backdrop of the Kota hospital incident in May, when five women had died after being administered spurious oxytocin injections.

After the first meeting, the matter has been recommended for further discussions, one of the officials said.

India has over 3,000 drug companies and 10,500 manufacturing facilities that supply to the domestic market as well as global supply chains.

Push for transparency

The plan is the latest in the regulator's push for transparency. As reported by Mint earlier, India’s apex drugs regulator also plans to make public the findings of inspections of pharma factories.

“The commissioner, food safety & drug control, government of Rajasthan, has forwarded a proposal regarding public disclosure of the quality-testing reports of drugs manufactured by pharmaceutical firms through a digital platform,” said the government document.

Under current drug laws, manufacturers can release a product for sale only after it has been tested either by itself or through a laboratory approved by the regulator. However, there's no need as of now for them to share the lab test results with intermediaries in the drug supply chain.

“…There is no such provision in the Act for maintaining the product test report at the level of C&FA/state druggist, nor is there any such provision requiring the manufacturer to forward the product test report to the carrying and forwarding agents (C&FA)/state druggist,” the document said.

“It is proposed that a suitable provision may be incorporated in the Drugs and Cosmetics Act, 1940 and Rules thereunder, 1945 for creation of a digital platform on which the quality-testing reports of drugs carried out by the manufacturers may be made available in the public domain to enable the general public to access the quality-testing reports of medicines being used by them, and thereby provide greater transparency regarding the quality of drugs,” it said.

'Information essential'

In an official communication to the DCGI, the Rajasthan drug controller noted that providing information to the general public about the quality of drugs is essential and that reports of quality testing conducted by manufacturers at their own level prior to marketing must be made public.

Industry experts, however, said the move may not be practical.

“Practically, universal digital disclosure is not possible. With manufacturers producing crores of batches and over 8 lakh retail chemists across India, making every record available to all consumers adds no serious value. Uday Bhaskar, former director general of Pharmexcil, an industry body for the sector's exports.

"Instead of these unfeasible plans, authorities should start by focusing on 'not of standard quality' products. Rather than merely uploading them to a website, that critical information must be communicated immediately down the line to every retailer, wholesaler, and consumer, backed by an effective drug recall mechanism. The priority must be actionable safety over digital platforms,” said Bhaskar.

Queries emailed to the spokesperson of health and family welfare ministry, the DCGI office and the Rajasthan drugs controller remained unanswered until press time.

About the Author

Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.