CDSCO (Central Drugs Standard Control Organisation)
Who regulates medicines in India?
In one sentence
The CDSCO is India's national drug regulator: an office of the health ministry, led by the Drugs Controller General, that approves new drugs.
It works under the Directorate General of Health Services in the Ministry of Health and Family Welfare; licensing most manufacture and sale is the states’ job. Adverse reaction reports go to a third body, the Pharmacovigilance Programme of India (PvPI) at the Indian Pharmacopoeia Commission in Ghaziabad, which sends them on to the World Health Organization (WHO).
Where it sits
- MinistryMinistry of Health and Family Welfare
- DirectorateDirectorate General of Health Services
- RegulatorCDSCO, New Delhi, led by the Drugs Controller General of India (DCGI)
- ReportsPvPI at the Indian Pharmacopoeia Commission, Ghaziabad1,200 monitoring centres feed it
Think of it like this
Think of a country where the licence to build comes from the capital, the inspector lives in your state, and the complaints book is kept by a third office in a neighbouring town.
Key insights
Under the Drugs and Cosmetics Act of 1940 the manufacture, sale and distribution of drugs are primarily the states’ concern. The centre approves new drugs and clinical trials, sets standards, checks imports and coordinates the state controllers; the Drugs Controller General licenses vaccines, sera and blood products. Chapter 1 tells how the split came about.
Reports do not come to the regulator first. Since 2011 the Pharmacovigilance Programme of India has been run from the Indian Pharmacopoeia Commission, which grew from 22 monitoring centres to 1,200 and had processed 1.09 million case reports by March 2026. It sends valid reports to Uppsala and its recommendations to the CDSCO. Chapter 2 sets the clocks.
A marketing authorisation holder reports every serious adverse event within 15 calendar days and every non-serious one within 90, from any source, to two inboxes at once: the CDSCO’s and the programme’s. New drugs add periodic safety update reports every six months for two years, then yearly for two more.
India joined the WHO Programme for International Drug Monitoring in 1998 and its programme is now the eighth-largest reporter of case reports, a WHO Collaborating Centre in its third term. The CDSCO sits at the International Council for Harmonisation (ICH) as an observer; in the International Coalition of Medicines Regulatory Authorities (ICMRA) India is represented by its ministry.
Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself
Chapter 1
Which three moments made the CDSCO what it is?
Pick a year. Each explains one of the three offices in the story.
An Act the provinces asked for
On 10 April 1940 India got “An Act to regulate the import, manufacture, distribution and sale of drugs”, passed after every provincial legislature had asked the centre to legislate for them under the 1935 constitution. Cosmetics came later; the shape did not change.
The Act created a Drugs Technical Advisory Board and a Central Drugs Laboratory, and left the licensing of manufacture and sale primarily to the states, with the centre approving new drugs, setting standards and checking imports. The organisation that discharges the centre’s functions is the CDSCO, headed by the Drugs Controller General of India.
What it left behind: one Act, two levels of government, and a regulator that coordinates more than it licenses.
A programme, relaunched
India tried pharmacovigilance several times before it stuck. The Drugs Controller General set up five monitoring centres in 1982; a research council study collected 58,000 reports in 1987 and stopped; India joined the WHO programme in 1998 with a Delhi medical institute as its centre; a national programme began in 2004 and was suspended in 2009. In July 2010 the CDSCO launched the Pharmacovigilance Programme of India with 22 monitoring centres.
On 15 April 2011 the ministry moved the programme’s coordinating centre to the Indian Pharmacopoeia Commission in Ghaziabad, where it has stayed. The centres send case reports through VigiFlow; the valid ones go to Uppsala, the findings to the CDSCO. By March 2026 there were 1,200 centres and 1.09 million reports, and the WHO had named the programme a Collaborating Centre for a third term.
What it left behind: a national database kept by a pharmacopoeia commission, not by the regulator.
New rules for new drugs
On 19 March 2019 the New Drugs and Clinical Trials Rules replaced the old schedule for trials and new drugs. They name the Drugs Controller, India as the Central Licensing Authority and make periodic safety update reports a condition of every new drug: every six months for two years, then yearly for two more, longer if public health needs it. A permission holder must also tell the authority of any serious adverse event within fifteen days of its occurrence.
The guidance for marketing authorisation holders, written by the programme in Ghaziabad with the CDSCO, was updated for the new rules and for the revised Schedule M, which requires every company to run a pharmacovigilance system. That guidance holds the clocks you meet in chapter 2.
What it left behind: a company rulebook written by two offices, with two inboxes to match.
Chapter 2
Your report, their clock
A case has reached your company. The guidance for marketing authorisation holders (MAH) sets the deadline with two questions: is it serious, and is the drug still new? Pick a cell.
Or it is not a single case: or
Every serious adverse event, from any source, is reported within 15 calendar days of receipt to two inboxes at once: the CDSCO’s and the programme’s coordinating centre’s, both by email. For a new drug under permission the 2019 Rules add a second duty: inform the Central Licensing Authority within fifteen days of the event’s occurrence. Guidance for marketing authorisation holders, 2.7.1; New Drugs and Clinical Trials Rules 2019, permission conditions
Every non-serious adverse event, from any source, is reported within 90 calendar days to the same two addresses, coded in MedDRA. Guidance for marketing authorisation holders, 2.7.2
A new drug’s periodic safety update report is due every six months for the first two years from approval, then once a year for the next two; the licensing authority may extend the period in the interest of public health. New Drugs and Clinical Trials Rules 2019, Fifth Schedule
Lack of efficacy and medication errors are adverse events too, and go to the programme and the regulator like any other. Guidance for marketing authorisation holders, note to 2.7.2
All Serious Adverse Events must be reported by MAH within 15 calendar days of receipt of information from any source.
Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAH), section 2.7.1: the clock, and the two inboxes that follow it
Doctors and patients report through the 1,200 monitoring centres in medical colleges and hospitals, or straight to the programme. The coordinating centre checks each case and sends the valid ones to the WHO database in Uppsala, where India is now the eighth-largest contributor.
Chapter 3
Side by side with Europe
Same clocks, a different map. Five places where India differs from the European Union (EU).
| The EU rule | The Indian rule | |
|---|---|---|
| Who decides | The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines | The Drugs Controller General, as Central Licensing Authority, for new drugs; the states license manufacture and sale |
| Where a serious case goes | EudraVigilance within 15 days, wherever it happened | Two emails within 15 calendar days, to the CDSCO and to the programme, from any source |
| A non-serious case | 90 days if it happened in the Union | 90 calendar days, wherever it happened |
| Who reads the report | The national competent authority and the EMA | A programme at the Indian Pharmacopoeia Commission, which forwards valid cases to the WHO and recommendations to the CDSCO |
| Hospitals as reporters | Member States encourage patients and professionals to report | 1,200 enrolled monitoring centres in medical colleges and hospitals report through VigiFlow |
Show the legal references
- Who decides: Regulation (EC) No 726/2004, Article 10(1); New Drugs and Clinical Trials Rules 2019, rule 3; CDSCO, Functions.
- Serious cases: Directive 2001/83/EC, Article 107(3); guidance for marketing authorisation holders, 2.7.1.
- Non-serious cases: Directive 2001/83/EC, Article 107(3); guidance for marketing authorisation holders, 2.7.2.
- Who reads: Directive 2001/83/EC, Article 102; the PvPI pages on data flow.
- Hospitals: Directive 2001/83/EC, Article 102(a); PvPI Newsletter, January to March 2026.
Europe’s deadlines, India’s geography: the case goes to Delhi and Ghaziabad in the same 15 days.
The facts, in one place
| What it is | The central drug authority under the Drugs and Cosmetics Act 1940, within the Directorate General of Health Services of the Ministry of Health and Family Welfare. |
|---|---|
| Since | The Act of 10 April 1940; the 2019 Rules for new drugs and trials since 19 March 2019. |
| Who decides | The Drugs Controller General of India, the Central Licensing Authority for new drugs; the Drugs Technical Advisory Board advises; six zonal offices, 13 port offices, seven laboratories. |
| Seat | New Delhi, Kotla Road. |
| Reports | To the Pharmacovigilance Programme of India at the Indian Pharmacopoeia Commission, Ghaziabad, since 15 April 2011. |
| The programme in numbers | 1,200 monitoring centres and 1.09 million case reports by March 2026; 188 drug safety alerts; the eighth-largest reporter to the WHO database. |
| Member of | The WHO Programme for International Drug Monitoring since 1998; the International Coalition of Medicines Regulatory Authorities (ICMRA), through the ministry; an observer at the International Council for Harmonisation (ICH); the programme is a WHO Collaborating Centre since 2017. |
Don’t confuse it with: the Indian Pharmacopoeia Commission
CDSCO
The regulator
- Decides: approval of new drugs and trials, import control, the critical licences
- Is: the central drug authority under the Act, led by the Drugs Controller General
- Example: acts on the programme’s recommendation about a drug
Indian Pharmacopoeia Commission
The standards body that keeps the reports
- Does: publishes the pharmacopoeia and hosts the national pharmacovigilance programme
- Is: a separate body of the same ministry, in Ghaziabad
- Example: checks a centre’s case, sends it to Uppsala, issues a safety alert
Chapter 4
Test yourself
Myth or Truth? Pick an answer to see the explanation.
“An Indian marketing authorisation holder reports serious cases to the CDSCO only.”
The guidance names two addresses: the CDSCO and the programme’s coordinating centre at the Indian Pharmacopoeia Commission, both within 15 calendar days.
“Non-serious adverse events have a 90-day clock in India.”
Section 2.7.2 of the guidance: all non-serious adverse events within 90 calendar days of receipt, from any source, to the same two inboxes.
Sources (13)
- CDSCO: About us, Introduction
- CDSCO: About us, Functions
- CDSCO: Home, About CDSCO
- The Drugs and Cosmetics Act, 1940 and Rules, 1945 (CDSCO, PDF)
- New Drugs and Clinical Trials Rules, 2019 (CDSCO, PDF)
- National Coordination Centre of the PvPI and CDSCO: Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (PDF)
- Indian Pharmacopoeia Commission: Pharmacovigilance Programme of India
- Indian Pharmacopoeia Commission: PvPI Profile, September 2025 (PDF)
- Indian Pharmacopoeia Commission: PvPI Newsletter, Vol. 16, Issue 1, January to March 2026 (PDF)
- ICMRA: Membership
- Food and Drug Administration (FDA): ICH overview (PDF)
- Directive 2001/83/EC, consolidated text (EUR-Lex)
- Regulation (EC) No 726/2004, consolidated text (EUR-Lex)
Last reviewed against these 13 sources. Every page is reviewed at least every six months.
