Under the Drugs Rules, 1945, Schedule H2 was introduced in 2022-23 to mandate printing barcodes or QR codes on the packaging of specific drugs. Initially applied only to the top 300 pharmaceutical brands to verify authenticity, the June 2026 expansion extends this to entire therapeutic classes of critical drugs (like vaccines, anti-cancer medicines, antimicrobials, and psychotropics). This shifts the regulatory focus from brand revenue to clinical risk, ensuring broader supply chain traceability.

Active Pharmaceutical Ingredients (APIs) are the raw chemical components responsible for the therapeutic effect of a medicine. For example, in a painkiller tablet, Paracetamol is the API, while binders and colors are excipients. India historically imported a major share of its APIs from China, leading the government to introduce production-linked incentive (PLI) schemes and stricter domestic regulatory oversight to ensure self-reliance and quality control.

The World Health Organization (WHO) defines substandard and falsified (SF) medical products as those that fail to meet quality standards or are deliberately misrepresented. According to WHO, an estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified, with antimicrobials and antimalarials being the most commonly reported, leading to thousands of preventable deaths annually and driving drug resistance.

Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi, and parasites evolve over time and no longer respond to medicines, making infections harder to treat. India has some of the highest AMR rates globally, driven by self-medication, overuse of antibiotics in livestock and humans, and the use of substandard antimicrobials. Substandard drugs provide sub-therapeutic doses, which fail to kill all pathogens, allowing drug-resistant strains to survive, multiply, and spread.

The Narcotics Control Bureau (NCB) is the apex drug law enforcement and intelligence agency of India, established in 1986 under the Narcotic Drugs and Psychotropic Substances (NDPS) Act. One of its primary concerns is ‘drug diversion’, the illegal redirection of prescription medicines (like pain-relieving opioids and sedatives) from legal supply chains (pharmacies, manufacturers) to the black market, which poses severe public health and security risks.

Between 2022 and 2023, cough syrups manufactured in India were linked to the deaths of over 140 children in The Gambia, Uzbekistan, and Cameroon due to acute kidney injury. The World Health Organization (WHO) and local regulators identified toxic levels of diethylene glycol (DEG) and ethylene glycol, industrial solvents used as cheap substitutes for pharmaceutical-grade solvents, in the syrups. This put India’s pharmaceutical regulatory framework on the defensive before global watchdogs like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), prompting mandatory WHO-Good Manufacturing Practices (GMP) upgrades for all Indian exporters.

The Office of the United States Trade Representative (USTR) releases the annual ‘Special 301 Report’, which reviews the global state of intellectual property rights (IPR) protection. In these reports, the USTR regularly places India on its ‘Priority Watch List’, citing challenges like patent backlog, trade secret protection issues, and the high volume of counterfeit pharmaceuticals. According to USTR and US Customs reports, India is identified as one of the leading global sources of counterfeit medicines seized at US borders or intercepted in transit.

The Jan Vishwas (Amendment of Provisions) Act, 2026, was enacted to reduce compliance burdens and promote ease of doing business in India. Under this Act, minor, procedural, or clerical violations under various laws, including the Drugs and Cosmetics Act, 1940, were decriminalized, replacing imprisonment with administrative fines and compounding of offences. However, it preserves criminal penalties for substantial non-compliance, such as manufacturing spurious or adulterated drugs, ensuring public health is not compromised.

India’s drug regulatory system faces a chronic shortage of drug inspectors and laboratory infrastructure. While the Mashelkar Committee (2003) recommended having at least one drug inspector per 200 manufacturing units and one per 200 sales outlets, the actual numbers are far lower. This regulatory capacity deficit makes it difficult to conduct regular factory inspections and market sampling, highlighting the urgent need for a ‘scale-up’ to effectively police the world’s pharmacy.