Centralized quality checking system for drugs proposed
Recently the Ministry of Health and Family Welfare (MoHFW) has proposed a centralized quality testing system for drugs.
MoHFW is preparing a proposal to create a centralized system of drug registration under the Central Drugs Standard Control Organization (CDSCO). This proposed system will keep a close watch on the quality of medicines.
CDSCO’s online portal ‘Sugam’ will be revamped keeping the above objective in mind. This portal monitors the quality of new drugs.
The MoHFW has taken this step in view of the reported deaths due to consumption of toxic Indian medicines abroad.
It may be noted that Indian-made cough syrups were blamed for child deaths due to drug poisoning in Gambia and Uzbekistan.
Drug Regulation in India-
- The Central Drugs Standard Control Organization (CDSCO) is the central drugs authority under the Ministry of Health and Family Welfare.
- It regulates the quality, safety and efficacy of drugs including vaccines under the New Drugs and Clinical Trials Rules, 2019 and the Drugs and Cosmetics Act, 1940.
- CDSCO gives permission to sell new drugs in the market (market authorization). Also, regulates clinical trial standards.
- In addition, it inspects the import of drugs and approves licenses for manufacturing.
- CDSCO also grants licenses for certain categories of critical drugs like blood, vaccines in collaboration with state drug regulators.
- CDSCO is headed by the Drugs Controller General of India (DCGI).
- The DCGI also acts as an appellate authority in case any dispute arises regarding the quality of drugs.
Challenges in ensuring the quality of drugs
- There is a lack of unified and interoperable labeling and identification standards.
- There is a lack of adequate number of testing facilities, inspectors and monitors.
- Pharmaceutical companies succeed in registering at the state level for new drugs failing to obtain approval from the CDSCO.
- There is an absence of any public database on the violations of regulations by any drug brand, its inspection reports and its past record.
Source – The Hindu
