Strengthening the Drug Regulatory System: Overview

Strengthening the Drug Regulatory System: Overview

Question: CCEA has recently given approval for strengthening the drug regulatory system at Centre and State level. Discuss.

- CCEA has recently given approval for strengthening the drug regulatory system at centre and state levels

- It is pegged at a total cost of INR 1750 crore

- Strengthening and upgradation of system will be spread over three years

- From total amount of INR 1750 crore, amount of INR 900 crore will be associated with strengthening central structures and INR 850 crore will be available to the State Governments following signing of MoU

Upgradation includes provisions for the following:

- Additional equipment and manpower in existing drug testing labs;

- Setting up of new laboratories for testing drugs,

- Medical devices and cosmetics;

- Making mobile drug testing laboratories available;

- Creation of additional manpower for regulatory structures, including for new and emerging areas including biologicals and medical devices, stem cell, regenerative medicine, in addition to drugs.

- Upgradation also involves including e-Governance and IT enabled online services

- It also entails the establishment of a training academy for regulatory and drug testing officials at Centre and State level

- Help will also be provided to States for the strengthening of drug regulatory structures

- This will increase the efficacy, quality and safety of drugs along with other medical products manufactured in the nation

- It will also trigger growth of domestic medical devices sector

Facts and Stats

- India is one of the largest manufacturers of drugs and export pharma products to over 200 nations

- Implementation of the scheme will facilitate domestic manufacture of quality medical items and assist in the establishment of the medical devices and pharma industry along with biologicals and other areas

- Common training programmes also aim at ensuring uniform drug regulatory practices throughout the nation
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