India is a vast marketplace for drugs and cosmetics. There is a need for well-defined and strict compliances that curtail the production and selling of potentially harmful drugs. CDSCO, as an apex regulator, is doing a commendable job in this regard. CDSCO guidelines ensure the availability of safe drugs and cosmetics in India. This write-up will discuss the interplay between CDCSO guidelines and Public health safety.
Role played by CDSCO in India
CDSCO, which stands for Central Drugs Standard Control Organization, regulated and controlled Director General of Health Services, part of GOI’S Ministry of Health and Family welfare. CDSCO is authorized for approval of new medicines/drugs, Clinical Trials supervision, legislating the standards for Drugs, and overseeing imported drugs’ quality. Also, to harmonize the activities of State Drug Control Organizations, CDSCO imparts professional advice to maintain uniformity in the enforcement of the Drugs and Cosmetics Act.
CDSCO can grant registration for various purposes, and these purposes are mentioned below-
- Cosmetic Registration
- Test License
- Export NOC
- Ethics Committee
- Blood Bank and Blood Products
- Formulation Research and Development
- NOC for Dual Use
- BA/BE Approved sites.
Aspects covered by the CDSCO Guidelines
CDSCO guidelines broadly cover the following area;
- Ban of harmful drugs and cosmetics
- Grant of test license personal, NOCs for exports
- Test for drugs by Central Labs for efficacy and quality
- Publication of the Indian Pharmacopoeia
- Amendment to the D&C Rules
How are CDSCO guidelines protecting public health?
CDSCO has laid down various directions and guidelines that seek;
- Manufacturers to undergo clinical trial for the launch of new drug
- To probe the movement of the overseas drug against the prescribed standard
- To mandate the inclusion of standard artwork on the label of schedule x drug
- To curb the movement of generic drugs in the Indian marketplace
CDSCO guidelines in relation to electronic acceptance of applications
Intending to bring transparency, reliability, simplicity, accountability, promptness, and ease of business, the e-Governance at CDSCO through the SUGAM portal came into the picture. It is designed for national importance that directly reflects the Government’s DIGITAL INDIA initiatives and is a primary reason for reforms in the Indian Pharma Industry.
SUGAM authorizes the online submission of applications asking for approval related to medicines and medical devices, clinical trials, ethics committees, vaccines, and cosmetics. It also builds up approved drug records, manufacturers’ formulations, retailers’ and wholesalers’ in India. Also, SUGAM permits the proper digitization of the previous CDSCO records.
The prime objectives of the project are:
- They are establishing one window for various stakeholders involved within the processes of CDSCO.
- Consolidating the Indian Drug Regulatory Framework by simplifying the CDSCO processes.
- Grant of verified clearances by CDSCO without physical paperwork
- It provides transparency in drug governing processes and facilitates business for the pharmaceutical industry and its governing agencies.
- They are extending the reach of citizen-centric & consumer-centric information associated with the country’s quality and standard of medicines.
In a nutshell, we can say that CDSCO is persistently advancing to bring out transparency, accountability, and regularity in its services to ensure promptness, safety, potency, and quality of the medical product manufactured, imported, and distributed in India. In conclusion, it is fair to say that CDSCO guidelines are preserving the public interest with an utmost priority.