1.1. Competent authorities for authorisation

Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories (such as cosmetics or dietary supplements)?

• In India, the governance of medicinal products and medical devices is administered through a two-tiered system (ie, central and state level). At the central level, India’s national regulatory authority, Central Drugs Standard Control Organisation (CDSCO), headed by the Drug Controller General of India (DCGI), empowered through India’s central legislation, the Drugs and Cosmetics Act, 1940 (D&C Act) regulates, among other things, the licensing, approvals, oversight, marketing, manufacture, quality control and distribution of drugs and cosmetics in the country, including overseeing the State Drug Controllers (SDC). The CDSCO is also empowered to perform these functions in respect of medical devices by way of the Medical Devices Rules 2017 (MD Rules), which is a subordinate piece of legislation under the D&C Act.
• At the state level, SDC, operating under the overall supervision of the CDSCO, regulate the licensing, manufacturing, marketing and distribution of medicines and medical devices within their jurisdictions.
• By virtue of operation of the D&C Act and the Drugs and Cosmetics Rules 1945 (D&C Rules), the CDSCO is also the central agency for the licensing, distribution, manufacturing, quality control of cosmetics in India. Cosmetics, are also therefore, subject to the same two-tiered central and state level supervision and regulation, as drugs or medicinal products.
• Additionally, Ayurveda, Siddha, Unani and Homoeopathy medicines are recognised as ‘drugs’ under the D&C Act, but are governed by a distinct regulatory framework under the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy). The Ministry of AYUSH oversees the implementation of the relevant provisions for ASU and homoeopathic drugs, including the issuance of licences and certification under the D&C Rules.
• For products that fall outside of the scope of either drugs, cosmetics and medical devices, such as food supplements or nutraceuticals, the primary regulatory agency is the Food Safety and Standards Authority of India (FSSAI), empowered under the Food Safety and Standards Act 2006. The FSSAI, operating through its central and state licensing authorities, regulates the manufacture, storage, distribution, sale, import, labelling and quality standards of food supplements and nutraceuticals in India.

1.2 Approval framework

Describe (briefly) the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.

• The DCGI is the central authority responsible for the administering the regulatory framework for marketing approvals of both categories, medicinal products and medical devices.
• The D&C Rules set out the labelling and patient information regime for medicinal products requiring labels to carry the non-proprietary (generic) name of the drugs in a font size at least half that of the brand name, along with batch number, instructions for use, manufacturing and expiry dates, storage conditions, maximum retail price, and details of the manufacturer and marketer. For imported drugs, the label must additionally disclose the name and address of the importing entity, along with its import licence number, and imported packs must comply with any India‑specific labelling sticker requirements under the D&C Rules. Prescription medicines carry mandatory caution statements based on their relevant classification under the D&C Act. Every marketed drug must be accompanied by a package insert containing technical prescribing information for healthcare professionals and, where applicable, a patient information leaflet in a language that is understandable to the consumer.
• For medical devices the MD Rules require labels to include the name of the device, manufacturers’ and importers’ details including authorised importer’s name and address together with importer’s licence or registration number, batch or lot number, manufacture and expiry dates (where applicable), sterility status, storage conditions and, where implemented, a unique device identification.

2.1 Applicable rules

What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?

• Clinical trials for both medicinal products and medical devices in India are primarily governed by the D&C Act, the D&C Rules, the New Drugs and Clinical Trials Rules 2019 (NDCT Rules); and, in the case of medical devices, the Medical Devices Rules 2017 (MD Rules). The NDCT Rules set out the procedures for clinical trials and approval of ‘new drugs’ for medicinal products, including biologicals and vaccines. The approval of new medical devices is governed under the MD Rules, which adopt a risk-based classification and regulatory system for medical devices and in vitro diagnostic devices. An Ethics Committee (EC), duly registered and set up under the Central Drugs Standard Control Organisation (CDSCO), is responsible for reviewing and approving any study involving human participants, including clinical trials of new drugs and regulated medical devices. The NDCT Rules prescribe a five-year validity for EC registration, with mandatory renewal and record maintenance requirements (NDCT Rules, Rule 9).
• Each EC is required to function under CDSCO-approved Standard Operating Procedures (SOPs), ensuring independence, quorum, and impartiality in decision-making (The New Drugs and Clinical Trial Rules 2019, Schedule III 3(3)(iii)). The ethical standards guiding EC decisions are drawn primarily from the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), which emphasise the principles of autonomy, beneficence, non-maleficence and justice, as well as international norms such as the Declaration of Helsinki (2013) and ICH-GCP (E6 R2) Guidelines (ICMR, National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017).
• The EC’s determination depends on whether the rights, safety, dignity and well-being of trial participants are adequately protected, and whether the anticipated benefits justify the potential risks. Under the SOPs, the EC undertakes a comprehensive review of every research proposal to ensure scientific validity, ethical integrity and participant safety. Special attention is given to vulnerable populations through additional protective measures such as enhanced consent protocols, post-trial care. ECs are also required to conduct continuing oversight of approved trials, including periodic review of progress reports, monitoring compliance with informed consent procedures and reporting of serious adverse events (NDCT Rules, 2019, Rule 11(iv)).

2.2 Reporting requirements

What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?

• Sponsors must submit a six-monthly status report for every clinical trial to the DCGI, confirming whether the study is ongoing, completed or terminated. Investigators are required to report any serious adverse event to the CDSCO, the sponsor and the EC within 24 hours, after which the sponsor must conduct a detailed assessment and file a full analysis with the CDSCO, the EC and the head of the trial site within 14 calendar days of becoming aware of the event.

2.3  Consent and insurance

Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?

• Trial participants must give freely given, written informed consent, supported by a patient information sheet and a consent form in a language they understand. The consent process must follow the format prescribed in the NDCT Rules, and in certain cases, such as trials involving vulnerable subjects or new chemical entities, the entire process must also be audio-video recorded. While sponsors are not mandatorily required to procure personal-injury insurance, they must furnish an undertaking under Rule 39(5) of the NDCT Rules to provide free medical management and compensation for any trial‑related injury or death, calculated in accordance with the formula set out in the Seventh Schedule. In addition, Clinical Research Organisations (CRO(s)) conducting clinical trials or bioavailability/bioequivalence studies must be registered with the CDSCO and maintain qualified personnel, SOPs and quality systems under the CRO registration framework introduced by the Ministry of Health and Family Welfare.

3.1 Time frame

How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

• Neither the Drugs and Cosmetics Rules 1945 (D&C Rules) nor the New Drugs and Clinical Trials Rules 2019 (NDCT Rules) prescribe a single, uniform statutory timeline for the grant of marketing authorisations in India. In practice, the duration depends on the category of product and the completeness of the application dossier. For drugs, marketing authorisations issued by Central Drugs Standard Control Organisation (CDSCO) are generally valid for five years unless suspended or cancelled, and renewal must be sought six months before expiry. For medical devices, licences and registration certificates issued under the Medical Devices Rules 2017 (MD Rules) remain valid in perpetuity, subject to payment of the prescribed retention fee every five years, unless the licence is suspended or revoked.
• The broad regulatory categories are set out below:

3.2 Marketing exclusivity

What protections or exclusivities apply to the marketing period of an approved medicinal product or variation?

• Indian law does not recognise any data or market-exclusivity period for an approved medicinal product or subsequent variation. Once a product is approved as per applicable law, the product competes in an open market subject to intellectual property rights law and regulatory compliance.

3.3 Protecting research data

What protections or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?

• Outside of protections under intellectual property rights law, the Indian jurisdiction does not provide any specific statutory data exclusivity for originator submissions.
• Regulatory authorities, including CDSCO and Ethics Committees (ECs), are nevertheless bound to maintain strict confidentiality over proprietary data, study dossiers, clinical trial materials and unpublished technical information submitted by originators. This duty arises from the NDCT Rules, the MD Rules, the mandatory Standard Operating Procedure (SOP) and record-keeping framework applicable to ECs, and restricts disclosure of such material to third parties except where required by law.

3.4  Freedom of information

To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?

• Third parties ordinarily cannot obtain copies of confidential research dossiers submitted for authorisation to market medicinal products or medical devices through freedom of information mechanisms. No specific inspection rights have been prescribed under applicable laws for third parties to procure this information. The regulatory submissions are largely confidential.

3.5 Regulation of specific medicinal products

What are the specific requirements and processes for marketing approval of the major categories of regulated products (including medicinal products; medical devices; biologicals and biosimilars; dietary supplements; and traditional herbal and homeopathic products)?

• Marketing approval for medicinal products is granted by CDSCO under the drug regulatory framework. Applicants must submit an online dossier with product quality data, pre-clinical studies and clinical evidence supporting safety and efficacy. ‘New drugs’ typically require local clinical trial data unless a waiver is justified (eg, for orphan indications or public-health need). Once approved, state authorities issue manufacturing licences, subject to Good Manufacturing Practices (GMP) inspection.
• Medical devices follow a risk-based regulatory pathway. Low and moderate-risk devices are generally licensed at the state level, while higher-risk devices require approval directly from CDSCO. The application includes device technical documentation, quality-management compliance (such as ISO 13485) and facility details. Importers are required to obtain a central licence before placing devices on the Indian market.
• Dietary Supplements and Nutraceuticals products are regulated as foods rather than drugs and require registration from the FSSAI. Applicants must ensure that ingredients, claims, purity standards, and labelling conform to applicable food-safety regulations before marketing. FSSAI grants registration/licence numbers displayed on all packaging before marketing.
• ASU and homeopathic products are regulated under the D&C Act. Manufacturers must obtain state licences issued after GMP inspections by the regulator. Classical formulations referenced in authoritative texts are exempt from pre-marketing clinical data, while proprietary or novel formulations require supporting safety and effectiveness evidence. Certifications such as AYUSH Standard Mark (Schedule T GMP) or AYUSH Premium Mark (WHO-GMP aligned) certification under the QCI-AYUSH Mark Scheme may also be obtained for voluntary quality assurance.
• Products that include narcotic or psychotropic ingredients require additional authorisations under the Narcotic Drugs and Psychotropic Substances Act 1985, with specific permissions needed for manufacture, possession, import or sale.
• Recent Supreme Court proceedings in Indian Medical Association v Union of India WP (C) 645/2022 have also tightened scrutiny of health‑related advertising across drugs, foods, nutraceuticals, AYUSH products and borderline cosmetics, including a self‑declaration regime for health and food advertisements and closer review of curative or therapeutic claims. Applicants should therefore align pre‑marketing dossiers, labelling and promotional materials with these heightened substantiation and advertising standards to mitigate post‑approval enforcement risk.

3.6 Rewards and incentives
What (if any) rewards or incentives for approval are applicable to the major product categories, including orphan drugs, drugs for paediatric use, generic drugs and biosimilars?

• Orphan drugs, defined in the NDCT Rules, may benefit from expedited CDSCO review and waiver of clinical trial application fees in accordance with the applicable regulations. India does not have separate statutory exclusivity incentives for paediatric use or biosimilars beyond procedural flexibilities. For generics and biosimilars, reliance on established data is permitted, subject to required equivalence studies and evidentiary standards being met.

3.7 Post‑marketing surveillance of safety

What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?

• For drugs, Schedule Y of the D&C Rules requires the marketing authorisation holder (including manufacturers and authorised importers) to maintain a pharma co-vigilance system to collect, assess and report adverse drug reactions. Periodic safety update reports must be submitted every six months for the first two years and annually for the next two years for new drugs covering, inter alia, new safety data, benefit-risk balance, global authorisation updates, proposed changes to product information, marketed formulations, strengths, dosage forms and any variation or reformulation. For an imported product, the importer is responsible for collating global safety data from the foreign manufacturer and ensuring that Indian PSURs and expedited ADR reports are filed with CDSCO.
• For medical devices, the MD Rules and the Materiovigilance Programme of India impose similar obligations. The licensed manufacturer, importer or relevant marketer (where applicable), must operate a post-market surveillance system, report device-related adverse events and malfunctions to the CDSCO and the Indian Pharmacopoeia Commission and take corrective or recall action if required. Continuous vigilance obligations include, inter alia, complaint handling, trend analysis and root-cause investigations, as well as monitoring software or component changes for ongoing safety performance and coordinating with foreign manufacturers, where applicable, to implement field safety corrective actions and global recalls in the Indian market.

3.8 Other authorisations

What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?

• Manufacturing of medicinal products requires a licence from the State Licensing Authority. Applicants must provide site details, equipment lists, product information, GMP evidence and qualifications of technical staff. Government fees are 6,000 rupees for up to 10 items plus 1,000 rupees per additional item, with an inspection fee of 1,500 rupees. Licences are valid in perpetuity, subject to a five-year retention fee equal to the original licence fee.
• Drug import requires a CDSCO registration certificate for the overseas site and products, followed by an import licence. Registration fees are US$1,500 per site and US$1,000 per product, with an optional US$5,000 inspection fee. Import-licence fees are 10,000 rupees for the first product and 1,000 rupees per additional product. Registration certificates are valid for three years, import licences remain valid in perpetuity unless suspended or cancelled.
• Drug exports do not require a separate export licence; however, a no objection certificate (NOC) is necessary for products not approved or not marketed in India. NOC applications require details on the manufacturing licence, product details and export order. WHO-GMP certificates or Certificates of Pharmaceutical Product are issued to meet destination-country requirements and the export shipment remains subject to applicable Indian foreign‑exchange, customs and export‑control regulations.
• State Licensing Authority issue licences for wholesale distribution and storage of drugs. Applicants must provide premises details, storage conditions, and qualifications of the pharmacist or competent person. Fees are 1,500 for grant and 1,500 for retention every five years, with a 2 per cent monthly late fee. No separate storage licence is required but storage must meet standards set out in Schedule P of the D&C Rules.
• Low and moderate-risk devices require registration from the State Licensing Authority (5,000 rupees per site and 500 rupees per device), while moderate-high and high-risk devices require CDSCO-issued manufacturing licences (50,000 rupees per site and 1,000 rupees per device). Applications must include the plant and device master files, ISO 13485 certification and product details. All licences are issued in perpetuity, subject to five-year retention at the same fee.
• Medical device importers must obtain a CDSCO-issued import licence by applying through an authorised Indian agent in Form MD-14. Required documents include the device master file, free sale certificate, QMS documents, and product labels. The import licence fee ranges from 1,000 to 50,000 rupees per site, with additional per-device fees depending on the class of device. Licences remain valid perpetually, subject to five-year retention with the same fee amount.
• Export of medical devices does not require a separate export authorisation. Manufacturers or importers may obtain a free sale certificate from CDSCO for overseas markets by submitting a valid licence and paying a fee of 1,000 rupees per device. The exporting activity remains subject to applicable Indian foreign‑exchange, customs and export‑control regulations.
• Wholesale distribution of devices requires a state registration certificate. Applicants must submit premises documents, a site plan, storage details and information on qualified technical staff. The fee is 3,000 rupees for initial registration and 3,000 rupees retention every five years.
• Further, in the event the wholesale distributor, retailer, manufacture or marketer has received foreign direct investment, the applicable provisions of the Foreign Exchange ManagementAct, 1999, the rules and regulations formulated thereunder read with the Consolidated FDI Policy 2020, would also need to be complied with. 

3.9 Sanctions

What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?

• Under the D&C Act, manufacturing or selling adulterated or spurious drugs or medical devices can lead to imprisonment of 10 years to life imprisonment and a minimum fine of 1 million rupees. Offences of lesser gravity carry three to five years’ imprisonment and fines. These offences can extend to any supply‑chain entity, including brand owners and marketers, where their activities amount to ‘manufacture for sale’ or ‘sale’ under the Act, and the MD Rules separately impose penalties, including recall obligations, and suspension or cancellation of licences for non-compliance.
• Authorities may suspend or revoke licences under the D&C Rules for breaches of conditions or GMP violations. Additionally, section 34 of the D&C Act holds the relevant company’s directors and officers personally liable if offences occur with their consent, connivance or neglect.

3.10 Exemptions

What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market (eg, preparation of a medicine by a pharmacist for a particular patient)?

• Exemptions are not ordinarily prescribed, however, limited carve‑outs exist under the D&C Rules, for instance: (1) drugs not intended for medicinal use provided that they are labelled appropriately; (2) certain specified antimalarials; and (3) supply by registered medical practitioners to their own patients or upon a practitioner’s request for an identified individual patient, in each case subject to compliance with applicable laws (the D&C Rules, Schedule K).3.11 Parallel trade

Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market. What are the requirements?

• Parallel imports without Indian licensing are not permitted (D&C Act, section 10(c)). Import into India requires prior registration and import licensing even if the product is authorised in another jurisdiction. All imported drugs must be licensed appropriately under the D&C Act and the D&C Rules for distribution, marketing, storage, wholesale and retail.

4.1 Variation

What are the main requirements relating to variation of authorisations for medicinal products and medical devices?

• For drugs, changes in the constitution of the firm (licensee) must be notified immediately in writing; existing registration typically remains valid only for a short transitional period, after which a fresh licence is required. Changes in indication, dosage form, strength or intended use for a ‘new drug’ require a fresh approval application. For devices, changes in constitution must be notified within prescribed time frames (generally 180 days for an import licensee and 45 days for a manufacturing licensee), with a fresh licence then issued. Variations are filed digitally via the SUGAM portal.

 4.2 Renewal

What are the main requirements relating to renewal of authorisations for medicinal products and medical devices?

• Renewals for drug licences are commonly required to be filed six months before expiry. Device licences are valid in perpetuity, subject to payment of a five-year retention fee.

 4.3 Transfer

How easy is it to transfer the existing approvals or rights to market medicines and medical devices? How long does this take in general?

• There is no statutory mechanism to transfer licences or marketing authorisations to another entity. In restructurings or business transfers, successor entities typically seek fresh licences or administrative endorsements.

5.1 Defective and unsafe products

What are the normal requirements for handling cases of defective or possibly unsafe products, including approvals required for recall and communication with health professionals?

• The Central Drugs Standard Control Organisation (CDSCO) Guidelines on Recall and Rapid Alert System for Drugs and the Drugs and Cosmetics framework govern drug recalls, classifying them into: Class I (serious risk, action within 72 hours), Class II (temporary risk, within 10 days), and Class III (unlikely to cause adverse effects, within 30 days), with recall levels at consumer/user, retail and wholesale. Manufacturers or marketers or importers must notify regulators, the supply chain and healthcare professionals promptly using the fastest available channels, maintain recall logs and conduct follow‑up actions.
• The Rapid Alert System now operates online and is used across all recall categories to issue NSQ/spurious drug notices and product-specific alerts to expedite field action. Once a recall decision in accordance with applicable laws is reached, the company must:
• issue recall communications (as per the relevant Class) to all consignees and healthcare facilities by the fastest available means, specifying the product, batch, risk and instructions to stop use and quarantine/return;
• publish public announcements for Class I recalls; and
• submit initial and follow-up recall reports to the licensing authority while maintaining a complete recall log until closure. Non-compliance may lead to suspension or cancellation of licences, prohibition orders or even attract penal action under sections 27 or 28B of the Drugs and Cosmetics Act (the D&C Act), including imprisonment of up to three years and monetary fines depending on the violation.
• For devices, the Medical Devices Rules require recall and notification to CDSCO within 15 days of awareness that a device poses a risk, with segregation and disposition under oversight, high‑risk devices receive priority handling. Non-compliance with recall obligations may result in suspension or cancellation of device licences, seizure or prohibition of sale of the affected lots, and prosecution (including fines and imprisonment) under the general penalty provisions of the D&C Act.

6.1 Regulation

Summarise the rules relating to advertising and promotion of medicinal products and medical devices (of different types, as appropriate), explaining when the provision of information will be treated as promotional (as opposed to merely corporate or financial information describing a company’s area of business and progress in research). Do special rules apply to online advertising?

• The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 (DMRA) prohibits advertisements of drugs claiming to diagnose, cure, mitigate, treat or prevent listed diseases and bans misleading or exaggerated claims. Advertising controls under the Drugs and Cosmetics Act (D&C Act) and the Medical Devices Rules 2017 (MD Rules) extend these restrictions to medical devices, as devices are now treated as ‘drugs’ for this purpose. Any promotional statement suggesting therapeutic benefit or superiority of a product may be considered objectionable under the DMRA and liable for penalty and/or prosecution.
• Under the Uniform Code for Pharmaceutical Marketing Practices 2024 (UCPMP), ‘promotion’ includes any informational or persuasive activity intended to induce product use. Neutral statements about research progress or financial results generally qualify as corporate information, whereas claims about efficacy, innovation or comparative advantage are deemed promotional and could be problematic unless backed with evidence. The same principles apply to medical devices under the Uniform Code for Marketing Practices in Medical Devices 2024 (UCMPMD). Both Codes apply across all media formats, including print, broadcast, digital platforms, social media, websites, events, and any direct or indirect communication to healthcare professionals or the public.
• Additionally, the Advertising Standards Council of India (ASCI) is a voluntary, non-statutory self-regulatory body that has set out a Code for self-regulation in advertising. Under its dedicated Healthcare and Wellness Advertising Guidelines, which apply across all media (print, TV, radio, digital platforms, social media, packaging, brochures, point-of-sale, etc), ASCI monitors promotional content related to medicines, medical devices, wellness products and treatments. ASCI’s findings may also be referred to statutory authorities, which can based on these findings initiate independent enforcement.

6.2 Inducement

What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

• Inducements to healthcare professionals are prohibited through professional ethics and industry codes. UCPMP and UCMPMD restrict gifts, travel, hospitality and monetary grants, require written agreements and fair market value for legitimate services, and mandate internal controls and records. Breaches may trigger professional, criminal and industry sanctions.6.3 Reporting transfers of value

What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

• Under UCPMP companies must maintain internal records of free samples distributed, capturing, inter alia, healthcare professionals’ name, product, date, quantity, as well as marketing expenses such as sponsorships, gifts, travel, hospitality and grants (The Uniform Code for Pharmaceutical Marketing Practices, 2024, Clauses 5 and 7). The code further mandates an annual self-declaration from CEOs and submission of a structured return of marketing expenditure (to the relevant industry association or, if unaffiliated, to the Department of Pharmaceuticals (DoP) portal) (The Uniform Code for Pharmaceutical Marketing Practices, 2024, Clause 14).
• Specifically for transfers of value like travel, conference sponsorships or grants to registered medical practitioners, UCPMP requires disclosures of events conducted, selection procedures for participants, funding sources and expenditure on the company’s website. The UCPMP further stipulates that free samples should not exceed 2 per cent of a company’s domestic sales annually and that brand-reminder items should be low value (ie, below 1,000 rupees per item) and meant for professional/ informational use only. Further, brand reminders must not have any standalone commercial value to the recipient (The Uniform Code for Pharmaceutical Marketing Practices, 2024, Clause 5.1).

6.4 Enforcers

Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

• In India, oversight of advertising and promotion of medicinal products and medical devices involves both statutory authorities and self-regulatory industry bodies. The statutory landscape is governed by the Central Drugs Standard Control Organisation (CDSCO), which provides oversight at the central level under the D&C Act, D&C Rules, and the DMRA for advertisements concerning medical products and devices. These laws collectively prohibit misleading claims, exaggerated or unfounded therapeutic assertions, deceptive promotional practices, with enforcement action initiated through the CDSCO. At state level, each state’s Food & Drug Administration or equivalent Drug Control Department handles licensing, inspection, investigation and enforcement of advertising controls for drugs and devices within the state’s jurisdiction.
• The self-regulatory framework is largely driven by the ASCI, which monitors advertisements across print, broadcast, digital media and adjudicates complaints through its Consumer Complaints Council and Fast Track mechanisms. Although ASCI is a non-statutory body, its directives are widely implemented by broadcasters and online platforms, and are supported through Ministry of Information & Broadcasting advisories, giving them significant practical force. The Healthcare guidelines, issued by ASCI, provide similar guidance on misleading claims, emphasising that health-related advertisements must not exaggerate efficacy, must be backed by adequate scientific or clinical substantiation, and must not exploit consumers’ lack of medical knowledge.
• The UCPMP and the analogous UCMPMD establish a structured self-regulatory compliance framework through ECs, state level review committees and national level appellate authorities, to monitor sectoral compliances. These bodies, inter alia, monitor compliance around marketing and promotional rules (eg, gifts, inducements, samples, transfers of value, etc), review of complaints around promotional material. While these codes are issued by the DoP and backed by government policy, adherence in practice operates through company‑level undertakings and industry‑association membership, with CEOs required to file periodic self‑declarations of compliance and to cooperate with any inquiries initiated via the DoP’s dedicated UCPMP/ UCMPMD portal.

6.5 Sanctions

What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

Breach of advertising and promotional controls for medicinal products and medical devices can attract criminal, administrative and industry penalties. Under the DMRA, publishing or participating in a prohibited or misleading advertisement is punishable with imprisonment up to 6 months and/or fine for a first offence, and up to one year for subsequent offences (The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, section 7). The D&C Act, further penalises misuse of analyst reports in advertisements with fines up to 5,000 rupees (The Drugs and Cosmetics Act 1940, section 29), and violations related to misbranding or false claims can trigger suspension or cancellation of product licences.

• Industry-level sanctions under the UCPMP, and the UCMPMD, include reprimands, withdrawal or correction of non-compliant materials, publication of breach findings, and suspension or expulsion from associations. The ASCI may also order modification or withdrawal of misleading consumer advertisements and refer serious violations to regulators.

7.1 Off‑label use

May health professionals prescribe or use products for ‘off-label’ indications (ones different to those for which the product was recommended by the originator and authorised by the competent authorities)? May pharmaceutical companies draw health professionals’ attention to potential off-label uses?

• There is no specific statute expressly authorising off‑label prescription. Promotion of off‑label uses by manufacturers is prohibited under advertising law and professional ethics frameworks.

 7.2 Unlicensed products

What rules apply to the manufacture and importation and supply to healthcare providers of unlicensed medicines or medical devices?

• Manufacture, importation or supply of medicines or medical devices without the prescribed licence is strictly prohibited under Indian law, and carries significant criminal penalties. The Drugs and Cosmetics Act 1940 (D&C Act) provides that whoever manufactures for sale, stocks, sells or distributes a drug without a valid licence (as required by section 18), or in contravention of the rules, shall be punishable with imprisonment for a term that shall not be less than three years but which may extend to five years and with fine that shall not be less than 1,00,000 rupees or three times the value of the drugs confiscated, whichever is more (the Drugs and Cosmetics Act 1940, section 27).
• More serious offences (for example, involving adulterated or spurious drugs, or where use causes death or grievous hurt) attract even harsher penalties, including imprisonment of five years to life and fines of at least 10,000 rupees or more (the Drugs and Cosmetics Act 1940, sections 27 and 27A).
• For importation of unlicensed or prohibited drugs, section 13 of the D&C Act provides that importing any drug deemed adulterated or spurious can lead to imprisonment of up to three years and a fine of up to 5,000 rupees in the first instance; and subsequent offences up to five years and up to 10,000 rupees.
• With regard to medical devices, the Medical Devices Rules 2017 (MD Rules) require importers and manufacturers of regulated medical devices to hold the appropriate licence or registration from the Central Drugs Standard Control Organisation (CDSCO) before supply. Any supply, manufacture or import of a device in contravention of MD Rules is subject to criminal prosecution including seizure or confiscation of stock or imprisonment and fine under the D&C Act.

7.3 Compassionate use

What rules apply to the establishment of compassionate use programmes for unlicensed products?

• India does not have a single, codified compassionate-use statute, but unlicensed products may be accessed through limited pathways administered by CDSCO. These include import of small quantities of unapproved drugs for personal use under the D&C Rules, named-patient or hospital-based requests for unapproved new drugs in serious or life-threatening conditions where no alternatives exist, and monitored emergency use of unregistered interventions under ICMR ethical guidelines during humanitarian emergencies. These routes rely on CDSCO permissions and ethics-committee oversight, rather than an expanded framework, with approvals remaining specific to each case.
• While NDCT Rules, together with draft amendments to the Rules propose permitting compassionate import by hospitals a dedicated statutory regime has not been finalised yet.

8.1 Regulation

Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

• The Drugs and Cosmetics framework governs sale and dispensing of allopathic and traditional systems under AYUSH. Particular product categories may have specific labelling and prescription controls.

 8.2 Online supply

What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

• Online sale of medicines and medical devices is presently governed primarily by the Drugs and Cosmetics Act (D&C Act) and Rules, which apply equally to digital channels, although the draft e-pharmacy rules, notified under the D&C Act have not yet been brought into force. Only licensed entities may stock, sell or dispense regulated products, and prescription medicines (Schedule H, H1 and X) may be supplied online only against a valid prescription.
• The Telemedicine Practice Guidelines (2020) permit registered medical practitioners to issue electronic prescriptions via audio, video or text consultations (excluding Schedule X and narcotic/psychotropic substances), which may then be fulfilled by licensed pharmacies online.
• In practice, companies and platforms operating online must therefore ensure valid prescriptions, verify licensing for stock and supply, maintain cold-chain or other storage/transport compliance as applicable, and adhere to digital data and privacy obligations. We understand that many large players have voluntarily aligned their policies and process with the unnotified draft e‑pharmacy framework as a matter of good practice and to remain ‘future‑ready’.

 8.3 Pricing and reimbursement

What are the controls (including health technology assessment of cost-effectiveness) imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

• India regulates pricing of medicines and certain medical devices primarily through the National Pharmaceutical Pricing Authority (NPPA) under the Drugs (Prices Control) Order 2013 (DPCO). NPPA fixes ceiling prices for essential drugs (NLEM) and for notified devices such as stents and knee implants, and monitors maximum retail price (MRP) of all other products. Price increases for scheduled formulations are limited to annual Wholesale Price Index-linked adjustments, non-scheduled products may increase prices up to 10 per cent annually unless specifically capped.
• For community-pharmacy supply, manufacturers, distributors and pharmacists must adhere to NPPA-fixed ceilings and defined margins (eg, 16 per cent retail margin for scheduled drugs). Distributors and retailers cannot sell above the ceiling price or permitted MRP, violations trigger overcharge recovery. For hospital and institutional supply, pricing is driven less by MRPs and more by tendering, pooled procurement and reimbursement package rates under voluntary schemes such as Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana, which operate as de facto price ceilings for implants, devices and reimbursed drugs.
• Generics, scheduled as NLEMs under the NPPA, must comply with DPCO ceilings where applicable and generally face downward pricing pressure from government generic-promotion schemes. Biosimilars, which are included in the NLEM list as scheduled formulations, would be subject to pricing regulation under the DPCO. Any drug, medical device or biosimilars that are not included in the NLEM are subject to market pricing.

9.1 Forthcoming legislation and regulation

Is there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?

• India’s pharma and device regulation is moving toward consolidation, centralisation and tougher enforcement. A draft Drugs, Medical Devices & Cosmetics Bill 2022 is set to replace the 1940 Drugs and Cosmetics Act, which will create a unified framework for drugs, devices and cosmetics, introduce a dedicated device chapter and technical board, tighten clinical‑trial and compensation rules, formalise licensing/standards for devices and e‑pharmacies, and significantly upgrade inspection and penalty powers.
• The Medicines and Medical Devices (Price Control and Accessibility) Bill 2025 would go beyond the current Pharmaceutical Pricing Authority/Drugs (Prices Control) Order 2013 model, to establish the National Pharmaceuticals and Medical Devices Pricing and Accessibility Authority and expand statutory control to a broader range of medicines and devices with powers to cap maximum retail prices and enforce fair pricing across essentially all medicines (including patented and over the counter).
• On the digital and distribution side, the Draft E‑Pharmacy Rules 2018 would, once notified, require mandatory registration/licensing of all e‑pharmacy portals, 24×7 pharmacist‑backed customer support and grievance redressal, strict data‑localisation and confidentiality, prohibition of certain high‑risk categories online, and give central and state regulators clearer powers to monitor online inventories and shut down non‑compliant platforms.
• The recent amendments to the Uniform Code for Pharmaceutical Marketing Practices 2024 and Uniform Code for Marketing Practices in Medical Devices 2024 lock in government‑backed self‑regulation of marketing conduct (gifts, inducements, sponsorships and promotional claims) via mandatory CEO certifications, record‑keeping and multi‑tier review/appellate bodies, requiring companies to tighten internal controls, promotional review processes and documentation around transfers of value.