The Drugs and Cosmetics Act, 1940 (DCA) is the main law that regulates medicines and cosmetic products in India. First called the “Drugs Act,” it was expanded in 1945 to include cosmetics. Its purpose is to ensure that all drugs and cosmetics made, imported, or sold in India are safe, effective, and of good quality. This protects people from fake or harmful products and supports the growth of India’s pharmaceutical industry. The law is enforced by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health. It was created based on the recommendations of the 1930 Chopra Committee, which warned about the danger of fake medicines. Over the years, the Act has been updated many times to address new issues like biosimilars and clinical trials. The Drugs and Cosmetics Rules, 1945, provide detailed guidelines on labelling, testing, and enforcement. As India’s pharma sector grows and is expected to reach $130 billion by 2030, the DCA remains essential for balancing innovation with public safety.
Historical Background
The DCA was created in pre-independence India when the drug market was largely unregulated and full of fake medicines, unsafe imports, and quack treatments. The Chopra Committee, set up in 1930, found serious problems like adulteration and misbranding, which pushed the government to pass a proper drug law. The Act was first passed under the Government of India Act, 1935, and started only as a law for drugs. In 1945, it was expanded to include cosmetics to meet new public health needs after World War II. After independence, more amendments were added: traditional systems like Ayurveda, Siddha, and Unani were recognized in 1964; stronger punishment for fake and spurious drugs was added in 1982; and stricter penalties came again in 2008. Medical devices were brought under regulation in 2020. Over time, the DCA has also adapted to global standards, including those of the WHO, and now covers modern areas like biosimilars, vaccines, and digital health. This evolution reflects India’s growing role as the “pharmacy of the world.”
Essential Provisions and Key Sections of the Drugs and Cosmetics Act, 1940
- The Drugs and Cosmetics Act, 1940, along with its Rules of 1945, is the principal law regulating the import, manufacture, sale, and distribution of drugs and cosmetics in India. Its primary objective is to ensure that only safe, efficacious, and quality products reach the public while preventing the circulation of misbranded, adulterated, or spurious items.
- Chapter I (Sections 1–3) contains the preliminary provisions. Section 1 defines the short title, extent (whole of India), and commencement. Section 2 is introductory in nature, whereas Section 3 provides exhaustive and inclusive definitions of critical terms such as “drug”, “cosmetic”, “misbranded drug/cosmetic”, “adulterated drug”, and “spurious drug”. The wide definition of “drug” under Section 3 covers allopathic medicines, medical devices, diagnostics, and even Ayurvedic, Siddha, and Unani formulations.
- Chapter II (Sections 5–7A) establishes the administrative and advisory machinery. It creates the Drugs Technical Advisory Board (DTAB) under Section 5 to advise the Central and State Governments, the Central Drugs Laboratory (CDL) under Section 6 for testing and analysis, and the Drugs Consultative Committee (DCC) under Section 7 to ensure uniformity between Centre and States. This chapter also provides for the appointment of Government Analysts and Drug Inspectors.
- Chapter III (Sections 8–15) governs the import of drugs and cosmetics. Section 9 prohibits the import of adulterated, misbranded, or spurious drugs/cosmetics. Section 10 makes registration certificates and import licences compulsory, and Section 10A empowers the Central Government to prohibit import of any drug likely to involve risk to human life or serious health hazards. Importers bear strict liability for compliance with prescribed standards.
- Chapter IV (Sections 16–33A) is the most extensive and operationally significant part of the Act, dealing with manufacture, sale, and distribution within India. Section 16 lays down standards of quality, while Sections 17, 17A, and 17B define misbranded, adulterated, and spurious drugs respectively. Section 18 prohibits manufacture or sale of such substandard or prohibited items. Licensing of manufacturing and sale premises is mandatory under the Rules framed under this chapter. Sections 22–25 confer wide powers on Drug Inspectors for inspection, sampling, search, seizure, and initiation of prosecution. The report of the Government Analyst is treated as conclusive evidence unless successfully rebutted.
- Chapter IV-A (Sections 33 B–33 O), inserted in 1964, provides a separate regulatory framework for Ayurvedic, Siddha, and Unani drugs. It establishes the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB), a separate Consultative Committee, and dedicated laboratories. Special standards, licensing requirements, and prohibitions apply exclusively to these traditional systems of medicine.
- Chapter V (Sections 26A–38) consolidates miscellaneous but powerful provisions. Section 26A authorises the Central Government to prohibit manufacture, sale, or distribution of any drug or cosmetic in public interest if it is found risky or lacking therapeutic value (this section has been frequently used to ban fixed-dose combinations and certain analgesics).
- Section 27 prescribes stringent penalties: life imprisonment and heavy fines for spurious or adulterated drugs causing death or grievous harm, and 7–10 years’ imprisonment in other cases of spurious/adulterated drugs. Section 34 fixes liability on directors and managers of companies, and Section 32 restricts initiation of prosecution to complaints filed by authorised Drug Inspectors or gazetted officers.
- The Act is supplemented by the Drugs and Cosmetics Rules, 1945, which contain detailed operational procedures, licence forms (Schedule A), lists of prescription drugs (Schedule H & H1), GMP requirements (Schedule M), and specific schedules for biologics, traditional medicines, shelf-life, and record-keeping. Subsequent amendments and new rules (e.g., New Drugs and Clinical Trials Rules, 2019; Medical Devices Rules, 2017) have further strengthened the regulatory framework.
In essence, the foundation of the Act rests on the definitions in Section 3, the licensing and quality standards in Chapter IV, the import controls in Chapter III, the special regime for traditional medicines in Chapter IV-A, and the strong enforcement powers under Sections 26A and 27 of Chapter V. Together, these provisions create a comprehensive system to safeguard public health in India.
Strengths of the Act
The Drugs and Cosmetics Act has greatly strengthened India’s drug regulation system and helped the country become a global leader in affordable generic medicines. It ensures strict quality checks and laboratory testing, which has brought down the incidence of substandard/not-of-standard-quality (NSQ) drugs from around 10% in the 1990s to approximately 3% in recent CDSCO sample surveys (2024–2025). The Act covers a wide range of products—from modern medicines and traditional systems like Ayurveda and Unani to newer areas such as medical devices and biosimilars—giving India a complete regulatory framework.
Strong penalties introduced through amendments act as a deterrent to violators, while bodies like DTAB and CDSCO, along with field officers, maintain regular inspections and enforcement. It also protects consumers by banning false labels and misleading claims and allows consumer groups to file complaints. Overall, these strengths have enabled India to supply 20% of the world’s generic medicines and over 60% of the world’s COVID-19 vaccine doses at the peak of the pandemic (2021–2022), saving billions in global healthcare costs.
Weaknesses and Criticisms
The Drugs and Cosmetics Act still faces major criticism because it is based on an old framework created in 1940, which makes it weak in handling today’s fast-changing healthcare and pharmaceutical environment. Many modern areas—such as digital pharmaceuticals, AI-driven drug development, and the growing market for nutraceuticals and health supplements—are not covered clearly by the Act. Even medical devices did not receive proper legal recognition until 2020, leaving a long period of regulatory gaps. As a result, the Act often struggles to match current industry needs, leading to confusion, slow enforcement, and difficulty in effectively regulating new technologies and products.
Operational and Administrative Obstacles
Enforcing the Drugs and Cosmetics Act (DCA) is difficult because the system lacks basic resources. India has far too few drug inspectors—only about one inspector for every 10 lakh people (2025 data: roughly 1,500 Drug Inspectors in position against an estimated requirement of over 3,000). This shortage causes delays in checking compliance, and because rules differ from state to state, enforcement becomes uneven. As a result, only about 20% of drug samples sent for testing are examined on time.
New businesses and medical innovation startups also face slow and complicated procedures. Getting the required licences can take up to 18 months, which discourages growth. Public trust has weakened due to repeated allegations of corruption. Although the government introduced reforms such as the New Drugs Rules of 2019 to simplify processes, the system is still not fully digital or fast.
Earlier, oversight of human clinical trials was also very weak. Before reforms triggered by ethical concerns (including incidents in 2013 and 2015 like the HPV vaccine case), the law did not provide strong, specific penalties for unethical clinical trials. Authorities had to use general criminal laws instead of targeted punishments, leaving major gaps in accountability.
Key Court Rulings
Indian courts, especially the Supreme Court, have played a major role in explaining how the Drugs and Cosmetics Act (DCA) should be enforced. Their rulings have clarified who can take legal action, how companies can be held responsible, and what kinds of products fall under the definition of “drugs.” In the 2024 Medley Pharmaceuticals case, the Supreme Court made it clear that only trained Drug Inspectors can start legal proceedings under Section 32. Police cannot register FIRs for offences under the Act.
This ensures that drug-related cases are handled by experts and helps prevent misuse of criminal laws. In the 2023 S. Athilakshmi case, the Court stated that a company director can be held guilty under Section 34 only if there is real evidence of their involvement. Simply being a director is not enough to prove responsibility, which protects individuals from unfair prosecution. The Court also expanded the law’s scope in the 2009 Baidyanath Ayurved ruling, where it held that Ayurvedic and traditional products count as “drugs” under Section 3(b) when they have medicinal properties or are used for treatment, even if marketed as health foods.
Courts have also helped strengthen the Act by pointing out gaps and pushing the government to update rules. In Ashok Kumar (2015), the Court highlighted weak penalties for unethical clinical trials, which later led to stricter rules in 2019. In the State of Karnataka (2008) ruling, the Court reinforced that senior company officials are responsible for substandard drugs unless they can prove they were not involved, leading to reforms in Section 34. Similarly, the Bhagwan Singh (1999) judgment stressed that pharmacies must issue a receipt for every sale, improving transparency and reducing illegal drug circulation. Together, these rulings have made enforcement clearer, strengthened accountability, and helped modernize the DCA to better protect public health.
Role of Police
Under the Drugs and Cosmetics Act, 1940, the police have a very limited and subordinate role. The Act designates Drug Inspectors (appointed under Section 21) as the primary investigating and enforcing authorities, and only they or officers specifically authorised by the Central/State Government can file complaints in court (Section 32). Police officers can act only when:
- a Drug Inspector is present and formally requisitions their assistance for search, seizure, or entry by force (Section 22(2) read with powers analogous to those under BNSS),
- a cognizable offence involving spurious/adulterated drugs that also attracts provisions of the Bhartiya Nyaya Sanhita (e.g., Sections 274–280 BNS or Section 318(4) BNS) is registered separately, or
- a magistrate issues a specific warrant or direction.
In routine enforcement and prosecution under the Drugs and Cosmetics Act, police have no independent power to inspect premises, draw samples, seize stocks, or launch prosecution; these powers are exclusively vested in the Drugs Control Department. Thus, the police play only a supportive role when called upon by the Drug Inspector and do not function as the primary enforcement agency under this statute.
Conclusion
The Drugs and Cosmetics Act, 1940 (DCA) has been very important for protecting people’s health and helping India’s medicine industry grow. It has clear rules—from basic definitions to strict punishments—that ensure only safe, good-quality medicines are made and sold. The Act is supported by expert bodies and strong enforcement systems. Although there are some problems, such as delays in implementation, the Act still works well because it follows high-quality standards and stays updated through amendments and important court decisions like the 2024 Medley ruling.
To make the Act ready for the future, India needs to adopt digital methods for licensing, use artificial intelligence for better monitoring, and follow global standards such as ICH guidelines. With new diseases emerging and the threat of antimicrobial resistance increasing, a strong and modern DCA is essential. This will require teamwork between the government, the courts, and the pharmaceutical industry to ensure safe and effective medicines reach everyone in the country.
