Mandatory CCTV at Medical Stores in Draft Amendment
for Prescription Drugs and Narcotics
Ø Schedule H, H1 & X Drugs, Transaction
Costs to Rise and Drug Inspector Harassment will Increase at the Cost of
Patient Welfare
Ø
Health
Ministry Proposes Amendments to Drugs Rules, 1945 to Strengthen Regulatory
Oversight of Schedule H, H1 and X Drugs
Ø
Mandatory
CCTV surveillance proposed at medical stores to enhance transparency and
accountability
1.
Draft Notification Issued
o
The Ministry of Health and Family Welfare
has proposed amendments to the Drugs Rules, 1945 through Draft
Gazette Notification G.S.R. 791(E) dated 8 September 2026.
2.
Objective
o
The proposal seeks to strengthen regulatory
oversight over Schedule H, H1 and X drugs.
o
It addresses concerns regarding unauthorized
access to and sale of these drugs.
3.
Mandatory CCTV Surveillance
o
The key proposal is to introduce mandatory CCTV
surveillance at medical stores.
o
CCTV would serve as an additional regulatory
safeguard for monitoring the sale and distribution of Schedule H, H1 and X
medicines.
4.
Drugs Consultative Committee (DCC)
o
The proposal was initially deliberated by the Drugs
Consultative Committee (DCC).
o
It was subsequently circulated to members of the Drugs
Technical Advisory Board (DTAB) for consideration.
5.
DTAB Recommendation
o
After considering the proposal, the DTAB
recommended its approval.
6.
Expected Regulatory Impact
o
The amendment is intended to strengthen monitoring
of the sale and distribution of Schedule H, H1 and X drugs.
o
It is expected to help curb their unauthorized
access and sale without valid prescriptions.
7.
Transparency & Accountability
o
The proposed CCTV mechanism is expected to enhance transparency
and accountability across the pharmaceutical supply chain.
o
It would provide an additional safeguard for public
health.
8.
Public Consultation
o
The Ministry has invited objections and
suggestions from stakeholders and members of the public on the proposed
amendment.
9.
Submission of Objections/Suggestions
o
Comments may be submitted to:
§ Under
Secretary (Drugs)
§ Ministry
of Health and Family Welfare
§ U-6, Work
Hall-C Wing, First Floor
§ Kartavya
Bhawan-1, New Delhi–110001
o
Email: drugsdiv-mohfw[at]gov[dot]in
Effect of
the Proposal
·
The proposal would add CCTV surveillance as a
regulatory safeguard at medical stores dealing with Schedule H, H1 and X
drugs.
·
The stated purpose is to improve monitoring and
help prevent sale without valid prescriptions and unauthorized access.
·
At this stage, it is a draft amendment open for
objections and suggestions, not yet a final amendment.
Union
Ministry of Health and Family Welfare has proposed amendments to the Drugs
Rules, 1945, through Draft Gazette Notification G.S.R.
791 (E) dated 8th September 2026, with the objective of strengthening
regulatory oversight over Schedule H, H1 and X drugs.
The
proposed amendment seeks to address concerns relating to unauthorized access to
and sale of Schedule H, H1 and X drugs and recommends mandatory CCTV
surveillance at medical stores as an additional regulatory safeguard.
The
proposal was initially deliberated upon by the Drugs Consultative Committee
(DCC) and was subsequently circulated among the members of the Drugs Technical
Advisory Board (DTAB) for deliberation. Following consideration of the
proposal, the DTAB recommended its approval.
Upon
implementation, the proposed amendment is expected to help strengthen
monitoring of the sale and distribution of Schedule H, H1 and X drugs and curb
their unauthorized access and sale without valid prescriptions.
The
proposed CCTV surveillance mechanism will also enhance transparency and
accountability across the pharmaceutical supply chain, thereby strengthening
safeguards for public health.
The
Ministry has invited objections and suggestions from stakeholders and members
of the public on the proposed amendment. Objections and suggestions, if any,
may be addressed to the Under Secretary (Drugs), Ministry of Health and Family
Welfare, Government of India, U-6, Work Hall-C Wing, First Floor, Kartavya
Bhawan-1, New Delhi–110001, or emailed at drugsdiv-mohfw[at]gov[dot]in.