RTI for Drug Approvals and CDSCO: A Guide for Patients, Journalists, and Researchers

India's pharmaceutical industry manufactures a significant share of the world's generic medicines, supplies vaccines to dozens of countries, and directly serves a domestic population of 1.4 billion. The Central Drugs Standard Control Organisation (CDSCO) sits at the centre of this ecosystem as India's national drug regulator — responsible for approving new drugs, licensing clinical trials, controlling drug imports, and co-ordinating with state drug authorities on manufacturing standards and market surveillance.

Given this scale and consequence, the question of what CDSCO actually knows and does — and when — is one of the most important public accountability questions in Indian healthcare. Health journalists and researchers have used the Right to Information Act, 2005 to expose regulatory approvals that lacked adequate safety data, to track adverse drug reaction reports that went unheeded, and to reveal patterns of drug quality failures that state authorities had been documenting without triggering central regulatory action.

This guide explains how patients, families, doctors, researchers, NGOs, and journalists can use RTI to access CDSCO's regulatory records.

CDSCO as a Public Authority

The Central Drugs Standard Control Organisation (CDSCO) functions under the Directorate General of Health Services (DGHS), which is under the Ministry of Health and Family Welfare. The Drugs Controller General of India (DCG(I)) heads CDSCO and is designated as the central licensing authority under the Drugs and Cosmetics Act, 1940.

CDSCO is unambiguously a "public authority" within the meaning of Section 2(h) of the Right to Information Act, 2005. It is established by law and exercises statutory powers. All RTI second appeals against CDSCO go to the Central Information Commission (CIC) under Section 19(3) — CDSCO is a Central Government body.

RTI applications to CDSCO are filed at rtionline.gov.in under the Ministry of Health and Family Welfare. The application fee is ₹10 under the RTI (Regulation of Fee and Cost) Rules, 2005. BPL cardholders are exempt from the fee under Section 7(5) and should upload their BPL card when filing online.

CDSCO's CPIO has 30 days to respond under Section 7(1). Failure to respond within 30 days constitutes deemed refusal under Section 7(2), triggering appeal rights.

State Drug Control Authorities: A Parallel Layer

Just as with food safety, drug regulation in India operates at two levels.

CDSCO (Central) handles: approval of new drugs (substances not previously approved in India), approval of clinical trials (Phase I, II, III), import licences for drugs and medical devices, licensing of central manufacturers (biologicals, large-volume parenterals), and central market surveillance.

State Drug Control Authorities (SDCAs) handle: manufacturing licences for most pharmaceutical manufacturers in their state, licences for retail chemists (drug stores), state-level market surveillance and sampling, prosecutions under the Drugs and Cosmetics Act for sub-standard or spurious drugs found within the state.

The State Drug Controllers are state government bodies. RTI filed with them goes to the state's CPIO, and second appeals go to the State Information Commission (SIC) — not the CIC.

The practical rule:

• New drug approval, clinical trial approval, import licence, adverse drug reaction (national level), product recall: file with CDSCO.
• Manufacturing licence compliance, state-level market sample results, retail chemist inspection: file with the State Drug Control Authority.

Use Case 1: Drug Approval Status

When a pharmaceutical company submits a new drug application to DCG(I) under Rule 101 of the Drugs and Cosmetics Rules, 1945, and patients or healthcare advocates want to know the status — whether the drug has been approved, rejected, or is pending — RTI is the appropriate mechanism in the absence of a public online tracker.

"Whether drug name / International Non-proprietary Name (INN) / brand name has received approval from DCG(I) / CDSCO for indication, e.g., treatment of Type 2 Diabetes / metastatic breast cancer. The date on which the application for approval was submitted by company name, if known. The date of approval or rejection. If rejected, the grounds for rejection as communicated to the applicant. If pending, the current stage of review."

For drugs already approved: CDSCO publishes some approval lists on its website, but historical approvals or approvals for specific indications may not be readily searchable. An RTI asking for the approval letter and the condition of approval is appropriate and has been used by health researchers to verify whether approvals were granted with adequate evidence.

Use Case 2: Clinical Trial Approvals

CDSCO's Subject Expert Committees (SECs) evaluate clinical trial applications before the DCG(I) grants permission under Schedule Y of the Drugs and Cosmetics Rules, 1945 (now superseded in part by the New Drugs and Clinical Trials Rules, 2019). Clinical trial approvals — which drugs, which sponsors, which trial sites, which patient populations — are public regulatory acts that have been subject to intense scrutiny following India's clinical trial controversies of the 2010s.

"The list of clinical trials approved by CDSCO/DCG(I) in year for disease category, e.g., oncology / infectious diseases / cardiovascular. For each trial, the IND (Investigational New Drug) application reference number, the drug name, the sponsor company, and the approved trial sites. A copy of the permission letter issued for clinical trial Protocol number/name approved to sponsor company for indication, dated approximately date."

Researchers tracking the Indian clinical trial landscape have found these RTI requests productive. CDSCO has a public registry (the Clinical Trials Registry — India, or CTRI, hosted by ICMR), but the CDSCO permission process and the SEC's deliberations are separate from CTRI registration and are accessible through RTI.

Use Case 3: Import Licences for Drugs and Medical Devices

Hospitals, procurement agencies, and civil society monitors have used RTI to verify whether specific drugs or medical devices imported into India hold a valid CDSCO import licence, and to understand the conditions under which the import was permitted.

"Whether import licence has been granted to company/importer name for import of drug name/medical device name/description bearing import application reference number X, or for imports made during year range. The date of the import licence, the licence number, and the conditions attached to the licence (including any risk-management conditions or post-marketing surveillance requirements). Whether this import licence has been renewed, suspended, or cancelled."

For situations where substandard imported goods are found in the market, RTI to CDSCO to verify the import licence and its conditions can be a critical step in tracing regulatory failure.

Use Case 4: Adverse Drug Reaction and Pharmacovigilance Records

India's national pharmacovigilance programme — the Pharmacovigilance Programme of India (PvPI) — is coordinated by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health and Family Welfare, with CDSCO as the regulatory authority that acts on signals from PvPI. Adverse drug reaction (ADR) reports submitted by prescribers and patients feed into this system.

When a pattern of serious ADRs has been reported for a specific drug — and citizens or healthcare professionals want to know what signal was generated and whether regulatory action followed — RTI is the appropriate tool:

"The number of adverse drug reaction (ADR) reports received by PvPI / CDSCO for drug name / INN in year(s). The nature of the ADRs reported (serious, non-serious; the categories of adverse events). Whether these reports generated a pharmacovigilance signal. The regulatory action taken by CDSCO in response to the ADR reports, including any communication to the marketing authorisation holder, label change requirement, risk communication issued, or restriction of use."

This type of RTI has been used by health journalists to expose situations where regulators were aware of safety signals for a drug but took no action for extended periods.

Use Case 5: Drug Recall and Market Withdrawal Orders

When a drug is found to be of substandard quality, contaminated, or unsafe, CDSCO can issue a recall direction. State drug authorities may also independently recall drugs found to be NSQ (Not of Standard Quality) in market sampling. The recall order and the compliance status are public regulatory records.

"Whether any quality/safety alert, voluntary recall notice, or mandatory recall direction has been issued by CDSCO for drug name / brand name / batch number manufactured by company name in year. A copy of the recall communication issued to the manufacturer and/or marketing authorisation holder. The compliance report submitted by the manufacturer/MAH after completion of the recall, including the total quantity of product withdrawn and the disposal method. Whether CDSCO has verified the recall completion."

For families who have used a recalled product — particularly in cases involving infant formula, vaccines, or critical care medicines — obtaining the regulatory paper trail through RTI is essential both for their own information and, if litigation follows, as evidence of the regulatory position.

Use Case 6: Substandard and Spurious Drugs in the Market

The Drugs and Cosmetics Act distinguishes between drugs that are "Not of Standard Quality" (NSQ — fail pharmacopoeial tests), "misbranded," "adulterated," and "spurious" (counterfeit). Market surveillance involves drug inspectors drawing samples from retail chemists, wholesalers, and manufacturing premises and sending them to government analysts.

For state-level market samples, the RTI is filed with the State Drug Control Authority. For central surveillance, file with CDSCO:

"Whether any sample of drug name / brand name manufactured by company name, manufacturing licence number if known drawn from the market in state/year has been found to be Not of Standard Quality, adulterated, misbranded, or spurious on analysis by a Government Analyst. If yes, the sample reference number, the parameter on which the sample failed, and the action taken against the manufacturer, including prosecution under Section 27 or 28 of the Drugs and Cosmetics Act, 1940."

This query can be directed to the State Drug Control Authority of the state where the sample was drawn, and separately to CDSCO for any central-level action (such as suspension of the manufacturing licence or issue of a national alert).

Use Case 7: Medical Device Registration and Classification

The Medical Devices Rules, 2017 (amended 2020 and subsequently) created a systematic registration regime for medical devices in India, with CDSCO as the central regulatory authority. Devices are classified as Class A through Class D based on risk. Higher-risk devices require CDSCO registration before import or domestic sale.

"The registration status of medical device name / description bearing device registration number X (if known) or manufactured by company name and intended for clinical use, under the Medical Devices Rules, 2017. The class to which this device is categorised (Class A/B/C/D). The date of registration and date of expiry. The manufacturing entity and the country of origin for imported devices."

For civil society organisations monitoring the market for unregistered medical devices — which are illegal under the Medical Devices Rules — RTI to CDSCO can confirm whether a specific device in circulation holds valid registration.

Use Case 8: State Drug Controller — Manufacturing Licence Compliance

For queries about manufacturing standards at a specific pharmaceutical facility — whether the manufacturer holds a valid licence, whether there have been inspections, and whether any non-compliance has been found — the RTI goes to the State Drug Controller of the state where the facility is located:

"The current status of manufacturing licence bearing number X issued to company name for the manufacturing facility at address. Whether this licence is currently valid and the date of expiry. Copies of the inspection report(s) conducted by the State Drug Inspector for the above facility in the past X years. Whether any show-cause notice, suspension notice, or cancellation order has been issued in respect of the above manufacturing licence, and if so, the grounds therefor."

This type of RTI has been used to expose what is sometimes called "licence-lending" — where a facility holds a manufacturing licence but is actually producing drugs for another company without proper oversight — as well as cases of recurring GMP non-compliance that state drug controllers had documented but not acted upon.

What RTI Cannot Easily Access: The Limits

Unpublished clinical trial data and proprietary formulation data: The clinical trial data submitted by a pharmaceutical company to CDSCO as part of a new drug application — Phase III trial results, pharmacokinetic data, manufacturing process details — is submitted under a claim of commercial confidentiality. CDSCO will typically invoke Section 8(1)(d) (trade secrets and commercially confidential information) to withhold it. This is generally a legitimate exemption, though health advocates argue that drug safety data ought to be subject to a different public interest balance.

Ongoing regulatory proceedings: If CDSCO or a state drug authority is currently investigating a manufacturer or pursuing a prosecution, Section 8(1)(h) (information that would impede investigation or prosecution) applies for the ongoing matter. For concluded proceedings, the exemption does not apply.

Third-party personal data: Information about the personal health history of clinical trial participants or individual patients who filed ADR reports is protected under Section 8(1)(j) — and legitimately so.

The Section 8(2) override: Even for information within an exemption, the RTI Act allows disclosure if the public interest in disclosure outweighs the harm. Drug safety information — particularly ADR signals and recall compliance — has a strong public interest argument that can be made in appeal before the CIC.

India's Drug Regulation Under Scrutiny: Why RTI Matters

India's drug regulatory system has been the subject of significant domestic and international scrutiny. A 2012 Parliamentary Standing Committee report, investigative journalism by multiple outlets, and academic research have all used or recommended RTI as a tool to assess regulatory decisions. RTI applications have exposed cases where new drug approvals were granted without adequate data, where ADR reports accumulated without regulatory response, and where state drug testing laboratories reported substandard samples from manufacturers who continued to operate.

CDSCO has also, in response to earlier RTI applications and media pressure, taken steps toward proactive disclosure — publishing some approval lists, making some SEC meeting records available, and creating online licence-verification tools. But gaps remain, and RTI continues to be the most reliable mechanism for obtaining specific, contemporaneous regulatory records that are not in any public database.

The Appeal Path

If CDSCO's CPIO does not respond within 30 days, responds inadequately, or refuses:

First Appeal under Section 19(1): File within 30 days of the decision (or the expiry of the 30-day deadline) with the First Appellate Authority within CDSCO — a senior officer designated for this purpose. No fee.

Second Appeal under Section 19(3): File within 90 days with the Central Information Commission (CIC). No fee. The CIC can order disclosure, impose penalties of ₹250/day up to ₹25,000 personally on the CPIO under Section 20, and award compensation.

For RTI filed with State Drug Control Authorities, the second appeal goes to the respective State Information Commission.

Filing: Portal and Address

RTI to CDSCO (Central Government body) is filed at rtionline.gov.in under Ministry of Health and Family Welfare → Central Drugs Standard Control Organisation / Directorate General of Health Services.

For state drug control authorities, each state has its own RTI filing mechanism — typically through the state government's RTI portal or offline postal application to the State Drug Controller's office.

How RTISathi Can Help

Drug regulation RTI applications require precision. Identifying whether your query belongs with CDSCO, the Indian Pharmacopoeia Commission (for PvPI), or the State Drug Controller; framing questions specific enough to extract regulatory outcomes without triggering broad commercial-confidentiality refusals; and navigating the CIC appeal when the response is inadequate — all of this requires working knowledge of both the RTI Act and India's drug regulatory architecture.

RTISathi.com provides end-to-end RTI filing assistance for health sector queries and all other RTI applications. We identify the correct public authority, draft the application in precise legal terms, file through the official portal, and handle First and Second Appeals to the CIC when needed. Our fee is ₹149 + GST per application, payable only after you've seen and approved the draft.

Visit RTISathi.com or write to [email protected] to get started.