India's apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), is refusing to make public crucial details about its inspections of pharmaceutical manufacturing units, citing confidentiality under the Right to Information (RTI) Act. This stance has ignited a fierce debate involving activists, retired officials, and public health experts who argue that such secrecy directly compromises drug safety and public interest.
The Veil of Secrecy Over Inspections
Despite announcing the commencement of a risk-based inspection model for drug-making facilities in December 2022, the CDSCO has declined to reveal how many such inspections have been conducted monthly since then. When queried under the RTI Act, the regulator claimed the information was exempt from disclosure. However, this blanket refusal is contested by seasoned professionals within the system.
Dr. KV Babu, an ophthalmologist and RTI activist who sought this information, strongly challenges this position. "The public has the right to know how many inspections were conducted each year, along with dates, company names, and the inspecting officers' details," he asserts. He emphasizes that drug inspectors are public functionaries funded by taxpayer money to ensure drug safety, and thus their work should be transparent.
Legal Exemptions: A Shield for Whom?
The drug authorities primarily invoke Section 8(1)(d) of the RTI Act, which exempts information that could harm a third party's commercial interests, unless public interest demands disclosure. The law explicitly states that public interest overrides commercial concerns. Another section cited is 8(1)(h), protecting information that could impede an investigation or prosecution.
An assistant drug controller, speaking on condition of anonymity, clarified that while reports from inspections leading to court cases might be withheld, details of all other inspections could be made public. "However, since no rule mandates disclosure, the default mode is to not reveal it," the official admitted. Dr. Babu counters the use of Section 8(1)(g)—meant to protect life and safety—by arguing that "not revealing inspection information is what truly endangers the lives of the public who consume these medicines."
Case Studies Highlight Systemic Failures
The urgency for transparency is underscored by recurring contamination scandals. CDSCO's own monthly drug alert lists repeatedly flag substandard products. A critical case involves Paschim Banga Pharmaceuticals, whose contaminated Ringer Lactate intravenous fluid was linked to the deaths of six new mothers in Karnataka. Shockingly, samples from this company were found contaminated with bacterial endotoxins multiple times: in April 2020, August 2023, October 2024, and November 2024, even after being connected to the fatalities. Contamination persisted in samples tested in December 2024, January 2025, and February 2025.
Similarly, products from Swaroop Pharmaceuticals in Aligarh, Uttar Pradesh, sold in Odisha, failed tests repeatedly from July to December 2022, and again in January, February, and December 2023. With no public inspection data, it is impossible to know if these facilities were ever inspected, what was found, or what corrective actions were ordered.
Diluted Regulations and Lack of Clarity
Ravi Uday Bhaskar, Director-General of the All India Drug Controller Officers Confederation, points to a regulatory dilution. "Earlier, every unit was inspected annually for licence renewal. This was diluted in the name of 'ease of business' to once every three years," he notes, advocating for patient-centric regulations.
Furthermore, the government's much-touted risk-based inspection framework lacks defined criteria, parameters, or methodology for determining risk levels. "This results in inconsistent interpretation across states and, in practice, a reduction in inspection frequency and oversight," explains Bhaskar. The regulatory focus remains skewed: while there are fewer than 8,000 manufacturing units (as per a 2023 government survey), resources are spent on testing samples from over 1.7 lakh pharmacies and distributors nationwide, rather than proactively inspecting production sites.
The opacity persists as RTI queries to the CDSCO and its 16 zonal offices continue to be stonewalled, leaving critical questions about India's drug safety infrastructure unanswered and raising alarming concerns for public health.
