Last Updated on September 17, 2026 by The Health Master

94th DTAB Meeting: Key Highlights

CDSCO Compliance & Regulatory Updates

The 94th meeting of the Drugs Technical Advisory Board (94th DTAB meeting) was held on 27th August 2026.

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The meeting was conducted in a hybrid mode with the chair being held by the Director General of Health Services (DGHS) and Drugs Controller General of India (DCGI).

The meeting resulted in several decisions on the approval of clinical trials, qualification of wholesale drug licenses and amendments to the Medical Devices Rules (MDR) 2017.

These regulatory decisions aim to improve the safety of drugs, streamline clinical trials and provide better regulation of medical devices and blood banks.

Download minutes of meeting of 94th DTAB held on 27-08-2026

Key Pharmaceutical Regulatory Developments

DTAB considered various issues related to manufacture, import and distribution of drugs and made some changes to ensure improved safety and ease of doing business.

Qualification of competent person in wholesale drug license:

The qualification of competent person for a wholesale drug license (Form 20B and 21B) has been specified as a Registered Pharmacist.

The large number of registered pharmacists in the country will help improve the supply chain.

Import and clinical trial approvals:

A “prior intimation” mechanism has been proposed for import of drugs for non-clinical and analytical use only.

The time to issue Form CT-17 has been reduced from 90 to 45 working days in order to facilitate research.

The “prior intimation” mechanism for BA-BE studies will also be extended for new drugs in India to provide a level playing field.

Good manufacturing practices (GMP):

Drugs to be used for non-clinical and analytical purposes must be manufactured as per GMP to ensure traceability in accordance with New Drugs and Clinical Trials (NDCT) Rules, 2019.

Blood banks (e-RaktKosh):

All blood centres shall be registered on e-RaktKosh.

Donors shall be authenticated through Aadhaar linked OTP or ABHA or Ayushman Bharat Digital Mission (ABDM) ID to ensure complete traceability of blood donors and prevent donations from deferred donors across multiple blood banks.

Expansion of import facilities:

To facilitate faster clearance of consignments, Rule 43A of the Drugs Rules, 1945 will be amended to include 10 new airports (including Noida International Airport), Inland Container Depots (ICDs) and Special Economic Zones (SEZs) namely ICDs in Hyderabad, Gujarat and Haryana and SEZs in Chennai, Coimbatore, Mumbai and Pune.

Prohibitions and Exemptions:

Lindane has been prohibited in manufacture, import and sale due to persistent organic pollutant issues.

No new nicotine products (such as nicotine pouches) shall be approved in the interest of de-addiction and public health.

Exemptions under Schedule K for sales of cough syrups have also been revoked following ratification of the notification issued by the Central Government.

Major Amendments to Medical Devices Rules (MDR) 2017

During the meeting, DTAB also focused on the improvement of the regulations related to medical devices and in vitro diagnostics (IVD).

Regulatory Domain	Approved Update
Test License Exemptions	Medical devices manufactured exclusively for test, evaluation, demonstration, or training purposes are now exempt from requiring a test license.
First Aid and Home Devices	Self-test devices like pulse oximeters, blood pressure monitors, pregnancy test kits, and thermometers, as well as imported first-aid kits for captive consumption by the automobile and hospitality industries, are exempt from certain sale and import licensing requirements.
Free Sale Certificates	Fees for obtaining a free sale certificate will now be charged per manufacturing license rather than per category of the medical device, reducing administrative ambiguity.
IVD Definition Harmonization	Rule 3 of the MDR 2017 will be updated to include an internationally harmonized definition for In Vitro Diagnostic (IVD) Medical Devices.
Post-Marketing Clinical Investigations	Rule 63 will explicitly include provisions for post-marketing clinical investigations via Form MD-22, accompanied by a structured fee of ₹1,00,000.
Testing Information Transparency	Forms MD-39 and MD-40 will be amended to include comprehensive details on the discipline, materials tested, specific parameters, and reference standards utilized by Medical Device Testing Laboratories.

 

These amendments are meant to bring about transparency, safety and efficiency in regulation of pharmaceuticals and medical devices.

Compliance with these new CDSCO regulations will be vital for manufacturers, distributors and

 

 

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DTAB

Technical Committee

Hathi Committee

Mashelkar Committee