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Pre-authorisation regulatory guidance for marketing of medicines in India


Rajdutt Shekhar Singh, Partner, Singh & Associates, shares insights on ways to effective marketing strategy

In order to persist in this highly competitive global pharmaceutical market, every organisation is required to have an effective marketing strategy and knowledge of various markets existing in the world. In this scenario, marketing of a medicinal product in India comprises regulatory compliances mandated by the Indian central regulating authority viz. Central Drug Standard Control Organisation (CDSCO) under the Drugs and Cosmetic Act, 1940 (Act) and Rules, 1945 (Rules) which evaluate the safety, efficacy and quality of drugs and also regulate their import, manufacturing, distribution, and sale in the country.

Any substance falling within the definition of ‘drug’ (Section 3 (b) of the Act) is required to be registered before importing and/or manufacturing in the country. In addition, manufacturing site (outside India) is also required to be registered.

Pre-approval stage checks

Prior to seeking and thereupon being granted authorisation to manufacture and distribute a drug, an applicant must run a diligence check on certain frequently encountered issues, which may pertain to:

Patent check: The applicant may need to check for patent affiliations that may be stemming from the drug being sought to be manufactured. In case of probable infringement, the applicant may need to apply for a license to use the patent from the owner or revise the production process. Further, if a novel technology is being employed for the manufacture of the drug, the applicant may also take steps to get the technology patented.

Price check: A fair evaluation of research and development (R&D) and other input costs will lead to the setting of a fair market price for the drug. This aspect is especially relevant when the drug in question is a life-saving medicine and is may be widely demanded by the public. The Drug Price Control Order regulates the pricing of such pharma substances.

Marketing approval of drugs

For obtaining permission to import or manufacture for the purpose of marketing of a drug product, an applicant is required to file an application in Form 44 along with prescribed fees in the form of treasury challan including all relevant data as per Schedule Y of the Act  and results of clinical trials on local population, if needed.

Division of drugs for marketing approval: Drugs can be divided into the following groups based on data required for marketing approval:

  • New chemical entity developed in India as an Investigational New Drugs (IND) and not marketed anywhere in world
  • New chemical entity approved & marketed in other countries but not approved in India.
  • New chemical entity being developed in other countries and not marketed anywhere in world
  • Other drugs: In addition to the above, requisite approval is required to be undertaken from CDSCO (i) for the drugs which are already approved by CDSCO for certain claims, which are now proposed to be marketed with modified or new claims (ii) a Fixed Dose Combination (FDC) of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.

Pharma marketing practices in India

Once the applicant receives marketing authorisation of a drug in India, it is also required to pursue a fair marketing practice and comply with regulatory compliances as described below:

Pharmaceutical advertising: The mandate set by the Supreme Court in the case of Hamdard Dawakhana (Wakf) v. Union of India and Ors makes it abundantly clear that commercial speech (in the form of advertisements), when pertaining to drugs and pharmaceutical products, must be cautiously aired. In light of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, it was held that labels/instructions on medicine bottles commending the therapeutic efficacy and value of a drug were prohibited since the intent of such advertising was to lure consumers into self-treatment.

Similarly, the Rules (Form 44, Form 46 and item No. 3 of Appendix IA) also direct an Applicant to provide relevant promotional literature, package inserts and draft specimens of the labels and cartons in which drugs are proposed to be sold for grant of authorisation to manufacture such drugs. The Drugs Controller General of India (DCGI) has also recommended the adoption of the self-regulation Code of the Advertising Standards Council of India with the objective of containing misleading and offensive ads. A recent advisory issued by the Ministry of Information and Broadcasting, with specific regard to ayurvedic and homeopathic medicines, directs television channels to comply with relevant laws and take off air, ads which promote self-medication and solution to health problems by self-proclaimed doctors and vaidhs.

Avoidance of unethical marketing practice: In order to curb unethical marketing practices for example luring of doctors to recommend a particular brand of drugs, by providing for paid trips often disguised as ‘educational conventions’ and other such incentives, the regulation for marketing practices (Uniform Code for Pharmaceuticals Marketing Practices), which is at present voluntary, will be made mandatory soon.


  1. 1960 SCR (2) 671
  3. sites/default/files/Uniform%20Code%20of%20Pharmaceuticals.pdf

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