Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) is India's national drug regulator. It decides which new medicines, vaccines and medical devices can be sold in India, approves clinical trials, controls imports and sets quality standards. It is headed by the Drugs Controller General of India (DCGI) and works under the Directorate General of Health Services, Ministry of Health and Family Welfare. Its powers come mainly from the Drugs and Cosmetics Act, 1940.

Why does it exist?

A medicine can save a life, but a fake, impure or untested medicine can kill. An ordinary patient cannot test a tablet before swallowing it. So a trained, neutral authority must check that every medicine is safe (does not cause unacceptable harm), effective (actually works) and of good quality (contains exactly what the label says). Think of it as the gatekeeper at the entrance of the medicine market.

Where did it come from?

In the 1930s, poor-quality imported medicines were a big problem in British India. The Drugs Enquiry Committee of 1931 (the Chopra Committee) recommended a law. This led to the Drugs Act, 1940, renamed the Drugs and Cosmetics Act, 1940 when cosmetics were added. The Drugs and Cosmetics Rules, 1945 give the detailed procedures. Over time, the government added newer rules:

• Medical Devices Rules, 2017, to regulate medical devices such as stents, syringes and diagnostic kits.
• New Drugs and Clinical Trials Rules, 2019, for approving new medicines and running clinical trials.
• A revised Schedule M (notified December 2023) with stricter Good Manufacturing Practices; small and medium makers were given until 31 December 2025 to comply.

How does the system work? (Centre vs states)

Drug regulation is shared between the Centre and the states. This is the most important point to understand.

• CDSCO (Centre) handles: approval of new drugs, permission for clinical trials, setting quality standards, licensing imports, approving certain categories such as vaccines and blood products, and coordinating with states.
• State drug controllers handle: licences to manufacture and to sell (pharmacies, wholesalers) most medicines, inspections of factories and shops in the state, and action against bad-quality medicines in the market.

So a company needs CDSCO's approval for a new drug, but its factory licence usually comes from the state where the factory is located. CDSCO has zonal and sub-zonal offices and port offices across the country, and runs central drug testing laboratories.

Advisory bodies under the Act

• Drugs Technical Advisory Board (DTAB): the highest technical body that advises the Centre and states on technical matters.
• Drugs Consultative Committee (DCC): a forum of central and state regulators to keep enforcement uniform across India.
• Central Drugs Laboratory: the national laboratory for testing drug samples.

Key legal categories of bad medicines (Drugs and Cosmetics Act)

• Not of Standard Quality (NSQ): does not meet the required quality standard (for example, wrong strength).
• Misbranded (Section 17): wrong or misleading label.
• Adulterated (Section 17A): mixed with harmful or impure substances.
• Spurious (Section 17B): fake, pretending to be another product or made by an unknown maker.

India's position and Indian examples

India is a huge producer of generic medicines and supplies many countries, so its regulator's reputation matters worldwide. Quality failures have hurt that reputation. In 2022, the World Health Organization linked Indian-made cough syrups to the deaths of about 70 children in The Gambia, and later to child deaths in Uzbekistan. In 2025, the cough syrup "Coldrif", found to contain the toxic chemical diethylene glycol far above safe limits, was linked to the deaths of more than 20 children in Madhya Pradesh.

These incidents led to stricter testing rules and to work on a new law to replace the 1940 Act; a draft Drugs, Medical Devices and Cosmetics Bill has been released for comments.

Commonly confused concepts

• CDSCO vs NPPA: CDSCO decides if a medicine is safe, effective and of good quality, and allows it into the market. NPPA (under the Department of Pharmaceuticals) decides its price. They are under different ministries.
• CDSCO vs DCGI: CDSCO is the organisation; the DCGI is the officer who heads it.
• CDSCO vs FSSAI: FSSAI regulates food safety; CDSCO regulates drugs, cosmetics and medical devices.
• Central vs state licensing: New drug approval is central; most manufacturing and sale licences are given by states.
• CDSCO vs Indian Pharmacopoeia Commission: The Pharmacopoeia Commission publishes the official book of drug standards (the Indian Pharmacopoeia); CDSCO enforces them.

Issues, criticism and the way forward

• Split powers: Because states license most factories and shops, standards of inspection vary widely between states.
• Too few inspectors: The Mashelkar Committee (2003) found far too few drug inspectors (about 935 against an estimated need of about 1,720) and recommended turning CDSCO into a stronger, independent Central Drug Administration.
• Parliamentary criticism: The 59th Report of the Parliamentary Standing Committee on Health and Family Welfare (2012) criticised CDSCO's approval processes and pointed to many vacant posts.
• Approval without value check: CDSCO checks safety and efficacy but not value for money, while NPPA sets prices without assessing clinical benefit. Experts suggest linking the two through Health Technology Assessment.
• Way forward: A modern law to replace the 1940 Act, more inspectors and labs, a central digital database of licences and test results, uniform enforcement in all states, and strict GMP compliance.

Concepts to Know

• Clinical trial: A carefully controlled test of a new medicine on human volunteers to check if it is safe and works.
• Generic medicine: A cheaper copy of a medicine whose patent has expired, with the same active ingredient and effect.
• Good Manufacturing Practices (GMP): A set of rules factories must follow (clean rooms, testing, records) so that every batch of a medicine is safe and of the same quality.
• Diethylene glycol (DEG): A toxic industrial chemical; when it is wrongly used in place of safe solvents in syrups, it damages the kidneys and can kill.
• Concurrent subject: "Drugs and poisons" is in the Concurrent List (Entry 19) of the Seventh Schedule of the Constitution, so both Centre and states can make laws on it.