Has your medicine maker been inspected? Can’t tell you, say drug regulators | India News

Inspection of drug manufacturing sites in India is confidential information that is exempt from public disclosure under the Right to Information according to the drug regulatory authorities. Though the Central Drug Standards Control Organisation (CDSCO) is supposed to have started risk-based inspection of drug-making facilities since December 2022, when asked how many such inspections have been conducted each month since then the CDSCO claimed that the information was exempt under the RTI Act. However, retired and active drug controllers pointed out that there was no blanket exemption on this information.“The public has the right to seek information on how many inspections have been conducted each year along with the dates of the inspections, the name of company and the names of the drug inspectors who conducted the inspection. Drug inspectors are public functionaries paid with public money to ensure safety of drugs in public interest. Why shouldn’t this information be available in the public domain, on the website of every state drug controller?” asked Dr KV Babu, ophthalmologist and RTI activist, who sought the information.Section 8(1) (d) cited by most drug authorities to deny information “exempts information the disclosure of which would prejudice the commercial interests of a third party, unless the public interest in disclosure is served”. The law clearly states that public interest overrides commercial interests.Section 8(1) (h) exempts “information that would impede the investigation or prosecution of offenders”. “This would only apply to those inspections which resulted in cases being filed as the drug authorities can claim that revealing the inspection reports could affect the case in court. But barring those inspection reports, the details of all other inspections can be made public. However, since there is no rule mandating the disclosure, the default mode is to not reveal it,” said an assistant drug controller who did not want to be named.Section (g) protects “information that would endanger life or physical safety, or identify sources of information for law enforcement”. “How does revealing this apply to information regarding inspection of drug-making facilities? If anything, not revealing it is endangering the life of the public who consume the medicines,” said Dr Babu.CDSCO’s drug alert list released every month shows that there are companies whose products are repeatedly found to be substandard with serious failings such as the presence of bacterial endotoxins and sterility issues in Ringer Lactate intravenous fluids. The products of one such company, Paschim Banga Pharmaceuticals, killed six new mothers in Karnataka, after which it was shut down. However, the Ringer Lactate fluid produced by this company was found contaminated with bacterial endotoxins in April 2020, again in August 2023, October 2024 and in November 2024 before it was connected to the deaths in Karnataka. Samples tested in December 2024 and those tested in January and February 2025 were also found similarly contaminated. However, with no data on inspections in the public domain, there is no way of knowing if drug control authorities ever inspected this unit before the deaths occurred or when they last inspected it or what they found if they did.Similarly, samples of yet another manufacturer of Ringer Lactate fluid, Swaroop Pharmaceuticals in Aligarh, Uttar Pradesh being sold in Odisha were found to be contaminated with bacterial endotoxins in July, August, September, October and December 2022. In January 2023, samples of the product lifted in Mizoram, in February in Odisha and again in December 2023 were found to be similarly contaminated. Yet there is no information in the public domain on whether inspections were conducted of the manufacturing facility of this company and what was found to be the reason for the repeated contamination. There is no information regarding any risk-based inspection of manufacturers of Ringer lactate fluid following the deaths in Karnataka.“Earlier, every unit had to be inspected once a year by state drug inspectors and every two years the licence had to be renewed after the unit was inspected to see if they are fit for renewal. This was diluted in the name of ‘ease of business’ and now inspections need to be done only once every three years. Framing of regulations ought to be patient/consumer centric and not to suit the business,” said Ravi Uday Bhaskar Director-General of All India Drug Controller Officers Confederation.Incidentally, there is no prioritization of inspection of manufacturing sites, from where drugs originate. Most of the drug regulation is in the form of lifting samples from an estimated 1.7 lakh pharmacies, stockists, distributors etc scattered across the country and getting them tested. In contrast there are less than 8,000 manufacturing units according to the 2023 report of the government’s survey of pharma clusters. According to the survey, there are 118 pharma clusters in India and 7,673 pharma manufacturing units.Though the government announced risk-based inspections, the rules do not specify any criteria, parameters or methodology to determine what constitutes a “risk-based” inspection or how manufacturers are to be categorized by risk level, making it open ended and discretionary. “This results in inconsistent interpretation across states and in practice, a reduction in inspection frequency and oversight, thereby diluting regulatory control over manufacturing compliance,” said Uday Bhaskar. RTIs queries to 16 zonal offices and the CDSCO on inspections have been stonewalled repeatedly.