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All you need to know about drug regulatory framework in India and the process of drug approval

A pharmaceutical company in India must have DGCI approval for selling a new prescription drug. Different countries or blocs have separate regulatory agencies tasked with reviewing new drugs and medical devices before companies can sell them.

June 21, 2022 / 07:41 PM IST

The office of the Drug Controller General of India (DCGI) is in the news after the Central Bureau of Investigation carried out searches in its Delhi premises and apprehended an official for allegedly taking a bribe of Rs 4 lakh to waive a clinical trial.

What exactly does the DCGI do, how is it related to other organisation such as MHRA and FDA, and how significant it is for pharma companies? Moneycontrol explains.

Who is the DCGI?

The drug controller general of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India. DCGI is the head of the pharma regulatory framework in the country.

What is CDSCO and what is its role in drug approval?


The CDSCO is a central drug authority under the Ministry of Health and Family Welfare that regulates the quality, safety, and efficacy of drugs including vaccines as per the provisions of the New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, 1940.

This organisation is the nodal authority for the approval of new drugs and clinical trials in the country. It lays down the standards for drug control over the quality of imported drugs.

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What are the other functions of the CDSCO?

The CDSCO also coordinates activities of several state drug control organisations and provides expert advice with a view to bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.

The CDSCO has the power to ban a drug that is considered harmful or sub-therapeutic under Section 26A of the act.

It is also responsible for granting licences to government hospitals or medical institutions to import drugs for the use of their patients.

Apart from these functions, the CDSCO is also a nodal authority for registering foreign manufacturers of drugs and medical devices that they want to ship to India.

What role does the DCGI’s office play in approval of drugs?

The office of the DCGI acts as an appellate authority if there is any dispute with respect to the quality of the drug.

The DCGI is also responsible for the approval of licences of specified categories of drugs such as blood and blood products, I V fluids, vaccines and sera.

Who does a pharma company approach before getting a drug onto the market?

A pharmaceutical company in India must have DGCI approval for selling a new prescription drug. The pharma company can approach the government regulatory agency in the countries they seek to sell the drug in. Different countries or blocs have separate regulatory agencies tasked with reviewing new drugs and medical devices before companies can sell them.

What is the process of drug approval in India?

A drug approval process comprises various stages: application to conduct clinical trials, conducting clinical trials, application for authorising the marketing of the drug and post-marketing studies.

In India, first a drug is tested on animals and the effectiveness in the animal model is assessed. If the results of the animal model are positive, the findings and study are sent to the DCGI office with a request for conducting human trials of the drug.

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At the DCGI office, a subject expert committee (SEC) evaluates the findings. If them to be satisfactory, the company gets permission for human trials to determine safety, immunogenicity and efficacy.

The SEC meets regularly to evaluate the results of trials and recommends the authorisation of drugs basis the results presented by the pharma companies in the three phases of human trials.

Every country has its own regulatory authority that is responsible for enforcing the rules and regulations and issuing guidelines to regulate the marketing of drugs.

What do state drug controllers do in India?

The state regulators are responsible for licensing the manufacture, sale and distribution of drugs in their respective states or union territories.

They also conduct checks for counterfeit or substandard drugs while also monitoring the quality of drugs in the state.

Why are regulatory affairs crucial for pharma companies before launching new drugs? 

Following proper regulatory affairs at different phases of drug development, approval and marketing helps pharmaceutical companies to ensure the quality, safety, and efficacy of the drugs.
Ayushman Kumar Covers health and pharma for MoneyControl.
first published: Jun 21, 2022 07:11 pm
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