**Executive Summary:**
This communication from the Drugs Controller General of India addresses concerns regarding the online sale of drugs in violation of the Drugs and Cosmetics Rules, 1945. It highlights potential risks to public health and directs State/UT Drugs Controllers to monitor online sales strictly and take action against violators. The communication also requests updates on actions taken.
**Key Points / Main Content:**
* **Context:**
* Representations received against ePharmacy raise concerns about violations of the Drugs and Cosmetics Act and Rules, endangering public health.
* Concerns include ineffective pharmacovigilance, impossible drug recalls, compromised storage, online sale of controlled substances, and encouragement of drug addiction.
* **Drugs Consultative Committee:**
* A sub-committee was formed under the chairmanship of Dr. Harshadeep Kamble to examine the issue of online medicine sales and its impact on public health.
* The sub-committee is consulting with stakeholders, including experts from IT, enforcement agencies, and the Medical Council of India, and has invited public comment.
* **Action Required:**
* State/UT Drugs Controllers are requested to maintain strict vigilance over online sales of medicines.
* Action must be taken against those violating the Drugs and Cosmetics Act and Rules to protect public health.
* The communication should be disseminated to all Licensing Authorities within their jurisdiction.
* The office of the Drugs Controller General of India must be informed of actions taken.
**Impact Analysis:**
* **State/UT Drugs Controllers:**
* *Impact:* Responsible for monitoring and enforcing regulations on online drug sales within their jurisdiction.
* *Action Required:* Implement strict monitoring of online medicine sales, take action against violators of the Drugs and Cosmetics Act and Rules, disseminate the communication to Licensing Authorities, and report actions taken to the Drugs Controller General of India.
* **Licensing Authorities:**
* *Impact:* Must adhere to the directives from the State/UT Drugs Controllers regarding the monitoring and enforcement of regulations on online drug sales.
* *Action Required:* Implement measures to monitor online drug sales and enforce compliance with the Drugs and Cosmetics Act and Rules as directed by the State/UT Drugs Controllers.
* **Online Pharmacies/Sellers:**
* *Impact:* Subject to increased scrutiny and potential enforcement actions if found to be in violation of the Drugs and Cosmetics Act and Rules.
* *Action Required:* Ensure full compliance with the Drugs and Cosmetics Act and Rules, including all regulations regarding the sale and distribution of drugs.
* **Public:**
* *Impact:* Potentially benefits from increased safety and regulation of online drug sales.
* *Action Required:* No direct action required, but encouraged to provide suggestions/comments to the sub-committee.
Key Entities Referenced
Drugs Controller General India: The regulatory authority in India responsible for the approval of drugs.
Drugs and Cosmetics Rules, 1945: A set of rules in India that regulate the sale and distribution of drugs and cosmetics.
ePharmacy: Online pharmacies that sell and distribute drugs over the internet.
Drugs and Cosmetics Act, 1940: An act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs Consultative Committee: A statutory body under the Drugs and Cosmetics Act, 1940.
Dr. Harshadeep Kamble, Commissioner, FDA, Maharashtra: Chairman of the sub-committee examining the sale of medicines over the internet.
FDA, Maharashtra: The Food and Drug Administration of Maharashtra state, India.
Department of Health and Family Welfare, New Delhi: A department of the Government of India.
No.7-5/2015/Misc/ (e-Governance)/091
Dte. General of Health Services
Office of Drugs Controller General (India)
FDA Bhawan, Kotla Road,
New Delhi - 110 002
Dated: 30.12.2015
To
All State/UT Drugs Controllers
Subject: Sale of drugs over Internet contravening the provisions
of Drugs and Cosmetics Rules, 1945
Sir,
The Drugs and Cosmetics Rules, 1945 inter alia regulate the sale
and distribution of drugs in the country. The Rules do not distinguish
between the conventional and over the Internet sale/distribution of
drugs. However, the provisions of the aforementioned rules have to be
complied in both cases. In the recent past, a spate of representations
have been received against e-Pharmacy from individuals, organizations,
trade bodies etc, An analysis of the representations has revealed that
serious concerns have been raised on issues impacting public health
such as gross violation of the provisions under Drugs and Cosmetic Act
and Rules, endangering human lives, rendering Pharmacovigilance
machinery ineffective, rendering drugs recall impossible, compromise of
storage conditions, danger of online sale of controlled substances,
encouragement of drug addiction among youth, etc.
The Drugs Consultative Committee, a statutory body under Drugs
and Cosmetics Act, 1940, in its 48 meeting, examined the issue of sale
of medicines over internet and after deliberations, constituted a sub-
committee under the chairmanship of Dr. Harshadeep Kamble,
Commissioner, FDA, Maharashtra, to examine issue of such sales via
internet, its impact on public health and also look into the provisions of
Drugs and Cosmetics Act, 1940 and Rules, 1945.
al2 Du
The sub-committee in its two subsequent meetings decided to
invite experts from the fields of Information Technology, National
Enforcement and Investigation Agencies, Medical council af India etc. to
understand their views on the subject matter. The sub-committee also
invited suggestions/comments from the public in this regard. The sub-
committee is currently in the process of consultation with all the
stakeholders.
The concerns raised in the representations, particularly those
relating to violation of Drugs and Cosmetics Act and Rules made
thereunder, safety and efficacy of medicines made available through
online sales can not be ignored/kept pending till the report of the sub-
committee constituted for this purpose becomes available.
In the above background, you are requested to put a strict vigil on
online sale of medicines and take action against those indulging in online
sale of medicines in violation of the Drugs and Cosmetics Act and Rules
thereunder, in the interest of public health. You are also requested to
disseminate this communication to all Licensing Authorities under your
jurisdiction for similar action in this regard. Further, you are also
requested to inform this office about the action taken from time to time
in the matter.
Yours faithfully,
<O3h-
a" Bafie| 2015-
(Dr. S. Eswara Reddy)
Joint Drugs Controller (1)
Copy to:
PPS to JS(R), Department of Health and Family Welfare, Nirman
Bhawan, New Delhi