Covid-19 has brought online pharmaceutical markets into the limelight in India. As a result, online pharmacies benefited from the pandemic. However, large-scale development of this sector will require huge investments and consolidation of a fragmented market.
Laws For Online Pharmacy Business: Introduction
The advent of online pharmacy, or online platforms facilitating the purchase of medicines, has transformed the pharmaceutical landscape in India. Offering the convenience of procuring medications without leaving the comfort of one’s home, these digital marketplaces operate similarly to other online platforms, delivering medicines directly to the consumer’s doorstep. The evolution of online pharmacy has seen improvements in terms of pricing, efficiency, accessibility, and supply chain, making them a commendable and innovative concept. all about knowing Laws For Online Pharmacy Business
India, a significant player in global pharmaceutical exports, contributes approximately 20%, with expectations to reach USD 22 billion by the end of 2020. The e-pharmacy market alone is poised to witness a substantial growth of INR 25,000 crores by 2022. This article delves into the regulatory framework surrounding online pharmacy in India, exploring the challenges and developments in this sector.
Regulatory Framework
The regulatory framework governing drug-related activities in India is primarily based on the Drugs and Cosmetics Act of 1940, along with several other acts and regulations such as the Pharmacy Act of 1948, Indian Medical Act of 1956, Code of Ethics Regulations of 2002, Narcotic Drugs and Psychotropic Substances Act of 1985, and Drugs and Magic Remedies (Objectionable Advertisement) Act of 1954.
The Drugs and Cosmetics Act, however, does not explicitly permit the home delivery of drugs. While it provides clear guidelines for the sale of restrictive drugs (Schedule H and Schedule X drugs), which require a prescription from a registered medical practitioner, it does not distinguish between online and offline pharmacies. Consequently, there is a lack of comprehensive regulation or policy specifically addressing the operations of pharmacies in the online domain.
Central Drugs Standard Control Organization (CDSCO)
In response to the absence of regulations concerning online drug sales, the CDSCO issued a notification on December 30, 2015, stating that selling drugs through the internet is not permitted, as it contravenes the provisions of the Drugs & Cosmetics Act of 1940 and the Rules of 1945. Recognizing the need for proper regulations related to packaging, sale, and safety standards in online pharmacies, the Drugs Consultative Committee (DCC), a statutory body under the CDSCO, established an expert sub-committee in 2015.
Chaired by Dr. Harshdeep Kamble, the ex-Food and Drug Commissioner of Maharashtra, this sub-committee was tasked with assessing the feasibility of the online pharmacy sector in India. The committee, in collaboration with the Ministry of Health and Family Welfare, proposed a draft to amend the Drugs and Cosmetics Rules of 1945. The draft aimed to filter out illegitimate suppliers and ensure the availability of genuine drugs to consumers.
Draft Rules for Online Pharmacy
The draft rules introduced the term ‘e-pharmacy,’ defining it as the business of distribution, sale, stock, exhibition, or offer for sale of drugs through a web portal or any other electronic mode. Key provisions of the draft included:
- Application for Registration
- Online pharmacy must apply for registration with the Central Licensing Authority.
- Conditions for registration include location, disclosure of information, and procedural guidelines for distribution and sale.
- Disclosure of Information
- Online pharmacy registration holders are prohibited from disclosing customer information obtained through prescriptions for purposes other than those intended.
- Information may be disclosed to the Central or State Government for public health purposes.
- Localized Data Storage
- Online pharmacy portals must establish data storage in India to ensure that data generated through the platform is localized.
- Restrictions and Monitoring
- Restrictions on the advertisement of drugs through various media channels.
- Monitoring mechanisms for complaint redressal, allowing consumers to file complaints about non-standard quality or misbranded drugs.
Opposition and Legal Challenges
Despite the regulatory initiative, several organizations representing chemists and druggists opposed online pharmacy. Concerns were raised about potential issues such as overuse of restricted drugs, self-medication without proper prescriptions, lack of face-to-face consultations with pharmacists, brand name confusion, ambiguity in the origin of brands, illegal export of drugs, and potential exploitation of customer’s personal information.
Delhi and Madras High Courts’ Response
Post-circulation of the draft rules, multiple petitions were filed at the Delhi and Madras High Courts, seeking a ban on all e-pharmacy operations to ensure public safety.
- Delhi High Court
Dr. Zaheer Ahmed, a dermatologist, filed a public interest litigation (PIL) expressing concerns about the risk of online sale of medicines to patients and doctors due to inadequate monitoring. The Delhi High Court responded by issuing an order prohibiting the online sale of drugs without a valid license (Zaheer Ahmed v. Union of India), enforced through a notification on the Drugs Controller General of India dated November 28, 2019.
- Madras High Court
The Madras High Court temporarily banned the online sale of drugs and urged the government to publish regulations, responding to a petition filed by the Tamil Nadu Chemists and Druggists Association on July 31, 2019.
Conclusion
The regulatory landscape for online pharmacy in India is evolving, marked by legal challenges and attempts to strike a balance between technological advancements and public safety. The pushback from traditional pharmacy stakeholders underscores the need for thorough and thoughtful regulations that address the unique challenges posed by online pharmaceutical sales.
As the legal proceedings unfold, the future of online pharmacy in India remains a dynamic and evolving landscape, influenced by advancements in technology, public health considerations, and regulatory frameworks.
For those seeking further assistance or information, feel free to comment below or contact us vakilsearch directly, as we navigate this complex and transformative terrain of Online Pharmacy in India.
FAQs on Online Pharmacy
What is the pharmaceutical industry in India?
The pharmaceutical industry in India is a significant contributor to the country's economy and is known for its low-cost generic drugs.
What are the key players in the Indian pharmaceutical industry?
The key players in the Indian pharmaceutical industry include Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Lupin, and Aurobindo Pharma.
What are the most commonly produced drugs in India?
The most commonly produced drugs in India include antibiotics, anti-inflammatory drugs, cardiovascular drugs, and anti-diabetic drugs.
What are the regulatory requirements for the pharmaceutical industry in India?
The regulatory requirements for the pharmaceutical industry in India include obtaining a license from the Drug Controller General of India (DCGI), complying with Good Manufacturing Practices (GMP), and registering with the Central Drugs Standard Control Organization (CDSCO).
What are the challenges faced by the pharmaceutical industry in India?
The challenges faced by the pharmaceutical industry in India include intellectual property rights, counterfeit drugs, and price controls.
What are the opportunities for the pharmaceutical industry in India?
The opportunities for the pharmaceutical industry in India include a large domestic market, a skilled workforce, and government support for research and development.
What are the export markets for Indian pharmaceutical companies?
The export markets for Indian pharmaceutical companies include the United States, Europe, and Africa.
What are the key trends in the Indian pharmaceutical industry?
The key trends in the Indian pharmaceutical industry include the growth of the biotechnology sector, the increasing focus on research and development, and the rising demand for speciality drugs.
What are the future prospects for the Indian pharmaceutical industry?
The future prospects for the Indian pharmaceutical industry are positive, with the government's focus on promoting research and development and the increasing demand for affordable drugs.
How can Indian pharmaceutical companies get support for their business?
Indian pharmaceutical companies can get support for their business from various government agencies such as the Ministry of Chemicals and Fertilizers, the Biotechnology Industry Partnership Program (BIPP), and the Indian Pharmaceutical Alliance (IPA). They can also seek assistance from trade associations and industry experts.
