Being a significant player in the global generic drug market, India has a strong and growing healthcare industry amid growing demand for affordable medications. A considerable portion of India’s healthcare budget is allocated to out-of-pocket spending on medications. Additionally, generic drugs are considerably more affordable, ranging from 30 to 80 per cent cheaper than their branded counterparts. Consequently, the popularity of generic drugs is increasing in India daily. Thus, it is relevant to understand the fundamental difference between a generic drug and a branded drug, along with their respective legal regulations.
MEANING OF GENERIC DRUGS AND BRANDED DRUGS
A generic drug is similar to a brand-name drug in terms of dosage, strength, administration, performance, and purpose. However, it lacks a proprietary brand name. Generic drugs are sold under their chemical or common names and do not have a brand name. Meanwhile, a branded drug is a formerly patented drug, manufactured and sold under a company’s brand name. The basic difference between a generic drug and a branded drug is the existence of a brand name. Generic drugs are identified by their active ingredients. On the other hand, the branded drugs are marketed under a brand name by the patent-holding company. Generic drug manufacturers benefit when patents for branded drugs expire. This allows them to manufacture and distribute generic versions of the branded drug, often at lower costs, leading to increased market share and potential profitability.
In India, the Central Drugs Standard Control Organisation (“CDSCO”) lays down the regulatory standards for drug control for generic and branded drugs. The Drugs and Cosmetics Act, 1940 (“Act”) and the Drugs and Cosmetics Rules, 1945 (“Rules”) regulate the import, manufacture, distribution, and sale of drugs. Thus, irrespective of whether the drug is generic or branded, compliance under the Act and the Rules remains the same.
Recently, the National Medical Commission released the National Medical Commission Registered Medical Practitioner (Professional Misconduct) Regulations, 2022. The regulations propose guidelines concerning generic and branded drugs. Though these regulations have not come into force yet, they mandate that registered medical practitioners must prescribe drugs only using generic names and not brand names.1 For example, instead of prescribing Crocin which is a brand name, registered medical practitioners shall mandatorily prescribe paracetamol as it is the generic name of a drug. There are exceptions to this requirement, which allows the prescription of branded drugs in case of drugs with narrow therapeutic index, biosimilars, and other similar exceptional cases. 2
The reason for such regulation is the government’s attempt to improve access to drugs by reducing the cost of healthcare, as generic medicines are priced lower than branded drugs. However, this mandate was not appreciated by the pharmaceutical industry, considering that there may be quality differences between the generic version of a branded drug and the loss of profit. Notably, in the earlier regulations, this practice of only prescribing generic drugs was a practitioner’s duty rather than a mandate.3 However, this position has been made compulsory in the new regulations.
The Pradhan Mantri Bhartiya Janaushadhi Pariyojana has been implemented by the Pharmaceuticals & Medical Devices Bureau of India, which has led to the establishment of Pradhan Mantri Bhartiya Janaushadhi Kendras. Under this scheme, more than 9512 Kendras provide quality generic medicines at 50-90% lower prices than branded medicines. The drugs are supplied by certified World Health Organisation-Good Manufacturing Practices (WHO-GMP) suppliers. The CDSCO has also taken various initiatives to promote the quality of generic drugs.4 The government has also launched a mobile application, ‘Janaushadhi Sugam’, that provides information to the public about the location of Kendras, helps them search for janaushadhi medicines and compares the maximum retail price of generic and branded medicines. This scheme also aims to educate people that generic medicines are the same as non-generic medicines and disapprove of the notion that they are ineffective because they are cheaper.
The Supreme Court of India has also taken a Public Interest Litigation (“PIL”) into consideration against medical practitioners prescribing branded medicines to patients. Presently, this PIL is pending before the Supreme Court.5
With an increased focus on healthcare and awareness about the efficacy of generic drugs, the market has increased demand for such drugs. However, legal healthcare compliances of a generic drug are no different from any branded drug. Therefore, in terms of healthcare compliance, persons involved in the supply chain of generic or branded drugs must comply with the Act and the Rules.
[1] Generic Medicine And Prescription Guidelines, National Medical Commission released the National Medical Commission Registered Medical Practitioner (Professional Misconduct) Regulations, 2022.
[2] Generic Medicine And Prescription Guidelines, National Medical Commission released the National Medical Commission Registered Medical Practitioner (Professional Misconduct) Regulations, 2022.
[3] Regulation 1.5, Indian Medical Council formulated (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
[4] Steps taken for Promotion of Generic Medicines, on 11th August 2023, available at https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1947689.
[5] Kishan Chand Jain v. Ethics and Medical Registration Board and Ors.| Writ Petition (Civil) No. 794 of 2023.
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