The Union Ministry of Health and Family Welfare has proposed amendments to the parameters listed in the Drugs Rules, 1945, which serve as the operation backbone of India’s drug regulatory system. According to an official press release published by the Press Information Bureau on Thursday morning, the new changes back the push for mandatory CCTV surveillanec at medical stores seek to strengthen regulatory oversight over prescription drugs.
Why have the new prescription drug rules been proposed?
The proposed amendment aims to curb concerns related to unauthorised access to and sale of Schedule H, H1 and X drugs. Deliberated upon by the Drugs Consultative Committee (DCC), the proposal was circulated among the members of the Drugs Technical Advisory Board (DTAB) for further consideration.
The board has since recommended that it be approved so that the sale and distribution of Schedule H, H1 and X drugs is monitored better and their unauthorised acess and sale without valid prescriptions can be prohibited.
“The proposed CCTV surveillance mechanism will also enhance transparency and accountability across the pharmaceutical supply chain, thereby strengthening safeguards for public health,” the official PIB release stated.
Schedule H refers to prescription-only medicines, including those tackling blood pressure and regular diabetes treatments that can’t be sold without a doctor’s prescription. Schedule H1, on the other hand, is a stricter sub-category which spans antibiotics and habit-forming sedatives.
Schedule X is the strictest tier as it includes high-risk narcotics and psychotropic substances with serious potential for abuse and addiction, according to Medyzen, a managed hospital pharmacy provider that installs AI-driven pharmacy kiosks inside hospitals and clinics.
Wholesale dealing won’t be impacted
According to the draft notification, the proposal won’t apply to wholesalers if implemented.
“The supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be made under a Closed-Circuit Television (CCTV) surveillance system installed and maintained for this purpose at the licensed premises,” it states.
The draft further notifies that CCTV footage will required to be preserved for three months, as per the proposed revisions.
Stakeholders and members of the public have been invited to submit their suggestions and objections to the proposal within 30 days.
The Delhi government has pushed for a similar CCTV mandate for its own medical stores last year. Back then, the All-India Organisation of Chemists adn Druggists (AIOCD) argued that regulating e-pharmacies was equally important, if not more, as imposing constraints on brick-and-mortar pharmacies.
The Union Health Ministry’s proposed amendments made headlines on September 17 just as US President Donald Trump praised Prime Minister Narendra Modi’s opium crackdown.
Notably, India remains on the United States‘ list of “major illicit drug producing or drug transit” countries. Other nations identified similarly in a Presidential Determination submitted to US Congress earlier this week are Afghanistan, The Bahamas, Belize, Bolivia, Burma, China, Colombia, Costa Rica, the Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Jamaica, Laos, Mexico, Nicaragua, Pakistan, Panama, Peru, and Venezuela.
“I welcome Prime Minister Modi and the Government of India’s efforts to address illicit opium poppy cultivation and bolster supply chain integrity,” the US Department of State said in a statement. “I look forward to continued cooperation through the United States-India Drug Policy Framework.”
The statement especially foregrounded that being designated on this list didn’t necessarily mean that the countries named therein had failed to combat drugs. They have been included in the list because geographic, commercial, and economic factors may have resulted in them emerging as undisputed transit or production hubs, despite the respective governments’ strict anti-narcotics regulations.