How to File RTI with CDSCO for Drug Approval, Medical Device Licence and Clinical Trial Records

The Central Drugs Standard Control Organisation (CDSCO) is India's national drug and medical device regulator, functioning under the Ministry of Health and Family Welfare. It derives its authority primarily from the Drugs and Cosmetics Act, 1940 and the rules framed thereunder — including the New Drugs and Clinical Trials (NDCT) Rules, 2019 and the Medical Devices Rules, 2017. Every new drug, every notified medical device, and every clinical trial conducted in India requires CDSCO's approval. Because CDSCO is a statutory Central Government body, it is a public authority under Section 2(h) of the RTI Act, 2005.

Healthcare professionals, patients, researchers, medical device manufacturers, and pharmaceutical companies can all use RTI to obtain precise, on-the-record information from CDSCO that is otherwise unavailable through public databases or routine correspondence.

What CDSCO Regulates and What You Can Access via RTI

CDSCO's regulatory mandate covers four broad domains, each of which generates disclosable records:

New Drug and Medical Device Approvals — CDSCO grants marketing approval (Manufacturing and Marketing Permission, or import licence) for new drugs and notified medical devices. The approval status, date of approval, approved indication, and the licence number are all regulatory facts that CDSCO holds and that do not ordinarily attract any exemption under Section 8 of the RTI Act. If a drug or device has been approved, this information is accessible. If an application is pending, RTI can reveal the current stage and any deficiency communicated to the applicant.

Clinical Trial Permissions — Under the NDCT Rules, 2019, pharmaceutical companies and academic institutions must obtain CDSCO permission before commencing clinical trials in India. The procedural facts of a permission — date, phase, number of sites, conditions imposed — are disclosable. Some commercially sensitive data submitted in the Clinical Trial Application (CTA), such as the company's proprietary preclinical data package, may be exempt under Section 8(1)(d) (commercial confidence). CDSCO can legitimately withhold that specific data, but it cannot withhold basic regulatory facts. An overly broad claim of Section 8(1)(d) covering the entire response can be challenged in a First Appeal.

Adverse Drug Reaction and Post-Market Safety Data — CDSCO coordinates with the Pharmacovigilance Programme of India (PvPI), operated through the Indian Pharmacopoeia Commission, to collect Adverse Drug Reaction (ADR) and adverse event (AE) reports. Aggregate counts of reports received for a specific drug or medical device since approval are statistical information that does not reveal individual patient identity and is fully disclosable through RTI.

Import Licences — CDSCO issues import licences for drugs and medical devices under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. The name of the import licence holder and the licence number are regulatory records that can be obtained via RTI.

Key Legislation You Should Know Before Filing

What Specific Information Can You Ask CDSCO?

Marketing approval status:

1. Whether marketing approval has been granted for drug/device name, and if so: date of approval, approved indication, licence number
2. If pending — current stage of the application, any deficiency communicated, and the prescribed regulatory timeline under NDCT Rules 2019 / Medical Devices Rules 2017
3. Copy of the approved Summary of Product Characteristics (SmPC) or device labelling filed at the time of approval

Clinical trial records: 4. Whether clinical trial permission was granted for drug/device; if yes: date, phase(s), number of approved trial sites, and conditions imposed 5. Whether any clinical trial for drug/device was suspended, restricted, or terminated by CDSCO — with the specific grounds cited

Adverse event data: 6. Aggregate number of ADR / adverse event reports received by CDSCO / PvPI for drug/device since marketing approval (or since clinical trial commencement) 7. Details of any post-market surveillance (PMS) study or post-market clinical follow-up (PMCF) findings submitted to CDSCO for drug/device, and any regulatory action taken

Import licences: 8. Name of the import licence holder and licence number for importation of drug/device under the Drugs and Cosmetics Act, 1940 / Medical Devices Rules, 2017 9. Whether the above import licence is currently valid, suspended, or cancelled

A Note on Section 8(1)(d) — Commercial Confidence

CDSCO receives large volumes of proprietary data from pharmaceutical and device companies as part of approval applications — preclinical study reports, formulation details, manufacturing process data, and clinical trial data packages. These can legitimately be withheld under Section 8(1)(d) of the RTI Act, which protects commercial confidence, trade secrets, and intellectual property where disclosure would harm the competitive position of a third party.

However, this exemption is not absolute and cannot be used as a blanket shield. Regulatory facts such as approval status, approval dates, approved indications, conditions of approval, and the existence of adverse event reports are not trade secrets. If CDSCO declines your entire RTI request citing Section 8(1)(d), you should file a First Appeal asserting that: (a) the exemption applies only to specific commercially sensitive data, not to procedural and regulatory information; and (b) Section 10 of the RTI Act requires severability — CDSCO must provide the non-exempt portions of the information requested.

Where to File

File online at rtionline.gov.in:

1. Select Ministry of Health and Family Welfare → Central Drugs Standard Control Organisation (CDSCO)
2. Address the application to the CPIO, CDSCO Headquarters, FDA Bhawan, Kotla Road, New Delhi – 110002
3. Pay the ₹10 fee online (net banking, debit card, or UPI). If you are a BPL cardholder, attach a copy of your BPL card and you are exempt from the fee.

CDSCO also has Zonal and Sub-Zonal offices (Mumbai, Kolkata, Chennai, Guwahati, Ahmedabad, Hyderabad). If your query relates specifically to a Zonal office's action (e.g., a drug sample tested at a Zonal laboratory), you may also address the application to the CPIO of the relevant Zonal office — but for national-level approvals, file at Headquarters.

Appeals

First Appeal (Section 19(1)): File with the First Appellate Authority (FAA) at CDSCO, FDA Bhawan, Kotla Road, New Delhi – 110002, within 30 days of the date of decision or expiry of the 30-day response period, whichever is applicable.

Second Appeal (Section 19(3)): File with the Central Information Commission (CIC) within 90 days of the date of the First Appellate Authority's decision or expiry of its response period. CDSCO is a Central Government body — the second appeal always goes to the CIC, not any State Information Commission. Persistent non-response can attract a penalty of up to ₹25,000 on the CPIO under Section 20 of the RTI Act.