INGRAM | Integrated Grievance Redressal Mechanism

1. What is a drug?

All medicines for internal or external use of human beings or animals and all substances intended to be used for, or, in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes

2. What is Cosmetic?

Cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

3. Under which act is the import of cosmetics regulated?

Import of cosmetic is regulated in India under the provisions of the Drugs & Cosmetic Act,1940 & Rules,1945.

4. What is the significance of the Act?

The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to quality standards. The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.

5. Which department regulates the approval of any drugs to be used in India?

Central Drugs Standard Control Organization (CDSCO) Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

6. What is the role of CDSCO.

Central Authorities are responsible for approval of New Drugs, Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations. For more information, refer the following link:- https://cdsco.gov.in/opencms/opencms/en/About-us/Functions/

Import of cosmetics in India is regulated to ensure quality of cosmetics being imported into India and safety of consumers using these cosmetics.

7. What are the Essential/ mandatory information that is required to be printed on the label of the medicine pack

The following information is required to be printed on the label of a medicine under the Drugs and Cosmetics Act and DPCO, 1995.

· Name of the formulation

· Composition of the formulation

· Pack Size

· Address of the manufacturer

· Manufacturing License Number

· Date of manufacture

· Expiry Date

· Maximum Retail Price

8. Where can a consumer register a grievance for the selling of medicines higher than the one printed?

Complaints on prices as well as quality of medicines can be lodged with the Drugs Inspector of the District or the State Drug Controller:

https://cdsco.gov.in/opencms/opencms/en/State-Drugs-Control/

9. How can a consumer get a product tested if he thinks it is fake or spurious?

By submitting the product to the government analyst and following the prescribed process of the same:

https://cdsco.gov.in/opencms/opencms/en/About-us/Laboratories/

10. Can a consumer lodge a grievance for the shopkeeper who is not taking the medicine back?

No, the consumer cannot lodge the grievance as it is the decision of the shopkeeper to take it back or not.

11. What is the role of NPPA?

The National Pharmaceutical Pricing Authority is a government body that regulates the price of drugs in India.

12. If any banned drug is being used in any state, where can the consumer register his grievance?

The consumer can register the grievance with the drug controller of the state and can also approach the Drug Controlle General of India.

https://cdsco.gov.in/opencms/opencms/en/State-Drugs-Control/

12. If a consumer uses a cosmetic product and faces irritation, then what he can do?

Consumer can register the grievance with the manufacturing company and with the drug controller of the concerned state and get the product checked by the government analyst. For more information, refer the following link:-

https://cdsco.gov.in/opencms/opencms/en/State-Drugs-Control/

13. If a consumer received adulterated or spurious drug, where he can complain?

Consumer can register the grievance with the manufacturing company and with the drug controller of that concerned state and get the product checked by the government analyst. For more information, refer the following link:-

https://cdsco.gov.in/opencms/opencms/en/State-Drugs-Control/

14. Is a bill necessary for any grievance registration related to drug and cosmetics?

Yes, a receipt or bill is mandatory.

15. Tier wise escalation level for consumer complaints handling.

Tier 1

Send first written complaint to the Company Customer Care by email, website or by post

Tier 2

If consumer does not receive any reply or is not satisfied with the response, he/she can file complaint to the Controller of Drugs & Cosmetic of the State/ Union territory.

Tier 3

In case the consumer is not satisfied with the resolution provided, he/she may file case with Consumer Dispute Redressal Commission, following the procedure prescribed by them. For more information, you may visit http://www.ncdrc.nic.in/districtlist.html