Planned Сhanges
On September 8, 2026, the Ministry of Health and Family Welfare of India published a draft amendment (Notification G.S.R. 791(E); hereinafter referred to as the "Draft") to the Drugs Rules, 1945 (hereinafter referred to as the "Rules"), according to which a pharmacy must dispense any prescription drugs under video surveillance that records the dispensing, and keep the recordings for at least three months. The Draft is primarily aimed at curbing the sale of drugs from Schedules H, H1 and X – three Schedules of prescription drugs according to the Rules:
-
Schedule H – common prescription medications (most antibiotics, hormones, and cardiovascular medications);
-
Schedule H1 – drugs with a risk of misuse (newer-generation antibiotics, anti-tuberculosis drugs, alprazolam, tramadol, etc.);
-
Schedule X – narcotic and psychotropic drugs for medical purposes (amphetamines, methylphenidate, etc.).
The Draft imposes the obligation to install and maintain a Closed-Circuit Television (CCTV) system on the pharmacy itself, and since the requirement is included in the terms of the retail sales license (new sub-rule (2A) of Rule 65 of the Rules), its violation may entail general sanctions up to suspension or cancellation of the license under Rule 66 of the Rules, which were adopted under the Drugs and Cosmetics Act, 1940. At the same time, the Draft does not yet contain technical requirements for cameras and record storage, the procedure for their inspection by the regulator, or specific sanctions.
A separate issue arises in the field of personal data regulation: the Draft does not specify who has the right to view and copy the records, when they can be transferred to third parties, and how to delete them after the storage period ends. Video recordings can be considered digital personal data within the meaning of Sections 2(n) and 2(t) of the Digital Personal Data Protection Act, 2023 (Act No. 22 of 2023; hereinafter referred to as the "DPDPA"), since they can be used to identify customers, and depending on the camera view, they may also indirectly indicate health information.
Industry associations have already filed objections: according to media reports, the All India Organisation of Chemists & Druggists (AIOCD) estimates the cost per pharmacy at INR 50,000–100,000 or more. The Punjab Pharmacists' Association pointed out the risk of disclosing information about patients' reproductive and mental health, as well as chronic diseases, and asked for clarification of the rules on access to and deletion of recordings.
Comparison with Russia
For companies operating in both markets, it is important to take into account the difference in approaches: in Russia, there is no general obligation to conduct video surveillance of the dispensing of medicines. Separate requirements for organizations involved in the circulation of narcotic and psychotropic drugs (Order No. 335 of Rosgvardiya and Order No. 677 of the Ministry of Internal Affairs of Russia, both dated September 15, 2021) require video surveillance only for protected premises and approaches to them at facilities with premises of the 1st category, to which pharmacies do not belong (clause 5 of Resolution of the Government of the Russian Federation No. 809 dated April 30, 2022). In any case, such video surveillance is necessary to protect against unauthorized entry and theft, and not to record dispensing.
In Russia, the task of confirming that a drug has been dispensed against a prescription is addressed by requiring pharmacies to retain prescriptions. The pharmacy keeps prescriptions for the following drugs (clause 5 of Appendix No. 2 and subclause “b” of clause 22 of Appendix No. 1 to Order of the Ministry of Health of Russia No. 100n dated March 7, 2025):
- narcotic and psychotropic drugs of Lists II and III of the List approved by Resolution of the Government of the Russian Federation No. 681 dated June 30, 1998 – for five years;
- other drugs subject to quantitative accounting (list approved by Order of the Ministry of Health of Russia No. 459n dated September 1, 2023), e.g. pregabalin – for three years;
- antipsychotics, anxiolytics, hypnotics and sedatives, and antidepressants not subject to such accounting – for three months.
In regions that have introduced electronic prescriptions, a paper prescription may be replaced by an electronic one signed with the doctor’s enhanced qualified electronic signature (clause 4 of Article 6 of Federal Law No. 61-FZ of April 12, 2010). In this case, the prescription is stored not at the pharmacy but in the regional healthcare information system.
At the same time, pharmacies have the right to conduct video surveillance on their own. In this case, the processing of personal data is regulated by Federal Law No. 152-FZ of July 27, 2006 "On Personal Data" (hereinafter referred to as "152-FZ"). However, if it is conducted for security purposes, and not for identification purposes, separate consent from visitors is not required: the pharmacy acts in its own legitimate interests, in particular, to protect against theft (clause 7 of Part 1 of Article 6 of 152-FZ).
Conclusions
The Draft has not yet been adopted, but its publication may indicate the direction of regulation in the country, so it makes sense for companies with a pharmacy business in India to prepare in advance and follow the publication of the final version.
If the Draft is adopted, companies will have to allocate a budget for the installation and maintenance of cameras and recording storage systems, and the size of the budget will depend on technical requirements, which may be specified in separate acts later. In addition, pharmacies will need to organize video data processing in line with the DPDPA: to determine who has access to records, under what conditions they are transferred to third parties, how they are protected and deleted after the storage period expires. We also recommend that you inform pharmacy visitors that there is video surveillance on the premises.