1. Authorities

Drugs
India

This section provides an overview of the Authorities involved in setting regulations and managing compliance with the food product in scope.

1. The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, Government of India

CDSCO under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, is the National Regulatory Authority (NRA) of India.           

Under the Drugs and Cosmetics Act 1940 (as amended up to the 31st December 2016) and rules 1945 (as amended up to the 31st December 2016), CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. 

The act is to regulate the import, manufacture, distribution, and sale of drugs [and cosmetics]; WHEREAS it is expedient to regulate the [import, manufacture, distribution, and sale] of drugs [and cosmetics]; AND WHEREAS the Legislature of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935, in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act. 

2. Central Consumer Protection Authority (CCPA) under the Department of Consumer Affairs

Central Consumer Protection Authority (CCPA) was set up under Section 10 of the Consumer Protection Act, 2019 in relation to matters affecting the rights of consumers.

The statutory functions of CCPA envisaged under Section 18 of the Consumer Protection Act, 2019 are to inquire or cause an inquiry or investigation to be made into violations of consumer rights and institute complaints/prosecution, order recall of unsafe goods and services, order discontinuation of unfair trade practices and misleading advertisements, impose penalties on manufacturers/endorsers/publishers of misleading advertisements.  

Enforcement activities of CCPA are carried out under the provisions stipulated under the Consumer Protection Act, 2019

3. Advertising Standards Council of India (ASCI)

The Advertising Standards Council of India is a voluntary self-regulatory organization of the advertising industry in India. Established in 1985, ASCI is registered as a non-profit company under section 25 of the Company Act. 

The council’s objectives are:

• To ensure the truthfulness and honesty of representations and claims made by advertisements.
• To ensure that advertisements are not offensive to generally accepted standards of public decency.
• To safeguard against the indiscriminate use of advertising for the promotion of products regarded as hazardous to society or to individuals.
• To ensure that advertisements observe fairness in competition so as to inform the consumer on choices in the marketplace while observing the canons of generally accepted competitive behavior in business.

The Consumer Complaints Council (CCC) is the complaint redressal wing of the ASCI which receives and considers complaints filed by the general public including consumer groups, government officials, and also suo moto complaints from the members of ASCI or CCC against the advertiser who contradicts the provision of the ASCI Code.

4. Telecom Regulatory Authority of India

The Telecom Regulatory Authority of India is a regulatory body set up by the Government of India under section 3 of the Telecom Regulatory Authority of India Act, 1997. It is the regulator of the telecommunications sector in India. Advertisements telecast on TV channels are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act, 1995 and the Rules framed thereunder.