66th meeting of the Drugs Consultative Committee (DCC): Gist

Last Updated on July 25, 2025 by The Health Master

DCC

The 66th meeting of the Drugs Consultative Committee (DCC) was conducted on June 17, 2025, at CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi.

The meeting was headed by Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General (India).

Various important topics were discussed in the meeting for strengthening the drug regulatory system across India.

Key agenda items and their outcomes include:

Action Taken Report of 65th DCC Meeting:

The Action Taken Report from the 65th DCC meeting, held on December 20, 2024, was deliberated and approved.

Sensitizing State Regulatory Authorities:

The DCC discussed the need to sensitize State Regulatory Authorities on various initiatives by the Ministry of Health and Family Welfare and CDSCO.

This includes:

• Ensuring revised Schedule M,
• Ensuring new drug permission from DCGI before issuance of permissions,
• Discussion on drug permissions without BA/BE study data for BCS Class II & IV drugs,
• Taking action on the outcomes of the Risk Based Inspections (RBI),
• Uploading the details of the manufacturer on online portal,
• Implementing the State Drug Regulatory Index,
• Capacity building for government drug testing laboratories,
• Onboarding on ONDLS, and
• Taking action against spurious and Not of Standard Quality (NSQ) drugs.

Availability of Pharmacists in Rural Areas:

It was discussed in detail on proposals to incorporate provisions under the Drugs Rules, 1945, to ensure availability of pharmacists in rural areas.

It was also proposed that State Licensing Authorities (SLAs) could assist professionals in registering as pharmacists if needed.

The committee noted the adequate number of pharmacy colleges and pharmacists, and existing provisions for restricted licenses that do not require a registered pharmacist were highlighted.

Amendment of Forms for Advanced Therapy Products:

The DCC agreed to amend Forms 27D, 27DA, 28D, and 28DA of the Drugs Rules, 1945, to include “Cell or Stem Cell derived products, Gene Therapeutic products or Xenografts, etc.“.

Regulation of Alcohol Content in Tinctures:

A proposal to amend the Drugs Rules, 1945, to regulate alcohol content in tinctures and other alcoholic preparations to curb illegal sales was agreed upon, including removing exemptions for alcoholic preparations with 30 ml or more alcohol content from Schedule K and including them in Schedule H1.

Exemption for Antiseptics from Wholesale/Retail Licences:

The committee agreed to amend Schedule K of the Drugs Rules, 1945, concerning exemptions from wholesale licenses for liquid antiseptics for household use and retail sale licenses for hospital-grade antiseptics.

Bar Code/QR Code on Drug Labels:

Despite some stakeholder concerns regarding usage rates and investment, the DCC agreed with the proposal to mandate Bar code/QR code on labels of all Vaccines, Antimicrobials, Anticancer, and Narcotics Drugs & Psychotropic Substances.

Regulation of Newer Anti-TB Drugs:

The DCC agreed to issue guidance to all SLAs to ensure that licenses for newer Anti-TB drugs (Bedaquiline, Delamanid, Pretomanid, and Rifapentine) include conditions for use as per Standards of TB Care in India (STCI) and conditional access through the National TB Elimination Programme (NTEP).

Labels will also carry a “WARNING: For the use in National TB Elimination Programme (NTEP)” in a red box.

Good Distribution Practices (GDP) Guidelines:

The DCC agreed to amend the Drugs Rules, 1945, to incorporate guidelines on Good Distribution Practices for pharmaceutical products.

Revision of Microbial Contamination Limits in Schedule M:

The DCC agreed that the limits for microbial contamination in “Grade A” areas mentioned in Schedule M should be amended to align with WHO TRS 1044 Annexure II.

Market Surveillance and Control Function:

Members agreed to take action as proposed by CDSCO for the Institutional Development Plan (IDP) on Market Surveillance and Control, recommending a detailed letter with SOPs/formats be sent to States/UTs.

Issuance of New Drug Licenses by SLAs:

The committee unanimously agreed that SLAs must obtain necessary permission from the Central Licensing Authority (CLA) before granting any manufacturing license for new drugs.

Consumer Concerns on Medicinal Product Labeling:

Recognizing issues like torn expiry date labels, shiny strip surfaces, small letters, and inconsistent medicine name placement, the DCC recommended forming a sub-committee with a packaging expert to evaluate these concerns and the feasibility of regulating packaging material suppliers.

Accessibility for Visually Impaired:

The DCC recommended placing the subcommittee’s report on CDSCO’s website for public comments, adding that secondary packaging with over 10 units of medicine could have braille cards and medicines could have QR codes linked with voice assistance.

Minamata Convention on Mercury on Cosmetics:

The DCC concluded that the Cosmetics Rules, 2020, are currently in line with the Minamata Convention, and no further amendment is required.

Guidelines for Not of Standard Quality (NSQ) Drugs:

The DCC noted a similar proposal for updating guidelines regarding spurious or NSQ drug samples was discussed in the 65th DCC meeting.

The meeting concluded with Dr. Rajeev Singh Raghuvanshi requesting all SLAs to monitor small marketing companies supplying medicines in rural areas to ensure accountability for quality standards.

Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.

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