New Delhi: In a first, India plans to publicly disclose findings from inspections of drug manufacturing units, marking a shift towards greater transparency and quality monitoring, according to two government officials and documents reviewed by Mint.
According to the proposal being discussed, the country’s apex drugs regulator, Central Drugs Standard Control Organization (CDSCO), will publish details of inspected firms and audit recommendations on its website, as India's pharmaceuticals sector faces heightened scrutiny over quality.
The plan assumes significance for the country's $50 billion pharmaceutical market in the backdrop of Indian-manufactured cough syrups being linked to over 140 deaths in countries, including Gambia, Uzbekistan and Cameroon, due to ethylene glycol poisoning.
The office of Drugs Controller General of India (DCGI), headed by Rajeev Raghuvanshi, conducts these risk-based inspections (RBI) to ensure compliance with regulatory requirements under the Drugs and Cosmetics Act and Rules.
“It has been desired that CDSCO may examine the feasibility of displaying brief details of firms inspected under RBI along with the recommendations of the inspection team, after due consideration of legal implications," according to the documents reviewed by Mint. "During such inspections, inspection teams make observations and recommendations based on risk assessment. However, at present, there is no system for public disclosure of these recommendations.”
Queries related to the plan emailed to the health and family welfare ministry and the DCGI on 30 March remained unanswered until press time.
The CDSCO, along with state drugs controllers (SDCs), conducted risk-based inspections of over 960 premises across the country since December, 2022; and based on these findings, more than 860 actions including issuance of show cause notices, stop production order, suspension, cancellation of licences/product licenses, and warning letters have been issued, according to Union minister of state for health Anupriya Patel in Lok Sabha on 27 March.
“Deliberations are still ongoing, because inspections are not the end. Their conclusions come much later after follow-ups and all, and they may have legal complications," said one of the above cited government officials, who requested anonymity. "The information can be displayed if there's any action.”
India, dubbed world’s biggest pharmacy, has over 3,000 pharma companies that run more than 10,500 factories. These units produce a range of products, including generics, active pharmaceutical ingredients (APIs), biologics and nutraceuticals.
A touch of caution
The industry favours the regulator's plan to increase transparency and quality oversight, albeit with a cautionary approach.
Dr. K. Anand Kumar, managing director of Indian Immunologicals Ltd said in a telephone call that risk-based approach to inspections is a desired move for the ecosystem, but is complex. "Given that regulatory resources are often limited, deploying them strategically is important. Pharmaceutical entities operate at varying levels of compliance and product complexity; a site manufacturing a single, low-complexity product requires a different oversight frequency than a facility handling multiple, highly complex processes,” Dr. Kumar said.
“By categorizing sites based on their risk profile and compliance history, wherein facilities with a long record of zero complaints and high standards are inspected less frequently, we can focus our enforcement efforts on habitual offenders or those with inadequate infrastructure," he said. "This initiative significantly enhances transparency, reduces human interference and ensures that the industry remains focused on quality, ultimately strengthening the global credibility of Indian pharmaceuticals.”
Hari Kiran Chereddi, chief executive officer and managing director at HRV Pharma said the move will bring a correction in the industry. “Making RBI findings public will force a reckoning: companies invested in quality will get recognition, while those masking deficiencies will be held accountable. This is the market correction India's pharmaceutical industry needs," Chereddi said, while also flagging caution. “First, the framework must precisely protect proprietary R&D details. Second, contextualization is vital; RBI findings are technical, and a 'major observation' doesn't always mean an unsafe product. Without standardized severity classifications, public misinterpretation is a risk."
"The CDSCO should co-design the disclosure format with industry stakeholders before going live. The direction is right; the design needs deliberation," said the CEO.
India's pharmaceutical industry is ranked third globally by volume and 14th by value. It supplies 20% of the world's generic medicines and 60% of the vaccines to over 200 countries.
Healthcare leaders said the move could strengthen quality oversight and patient safety.
Dr. Naresh Trehan, chairman and managing director at Gurugram-headquartered Medanta hospital said, “Quality is the most critical factor in patient care; if the medicine is not of standard quality, the patient simply will not respond to treatment,” he said. "Government surveillance and risk-based assessments are essential to ensure that available medicines meet these high standards. Patients should never be lured by cheaper prices for substandard products, as they lead to ineffective or sub-optimal health outcomes. Strict adherence to quality is non-negotiable.”
Legal experts noted that the plan's intent is clear, but the implications could remain open to interpretation.
“While it’s debatable whether the court of public opinion should cast aspersions over a company investigated by the CDSCO, the recent spate of adulterated medicines causing deaths tilts the balance in favour of notifying the public about companies which are being investigated. This would at least allow the public to have an opportunity to exercise caution whilst buying products from those brands,” said Akash Karmakar, partner at Law Offices of Panag & Babu and senior advisor at Flint Global.