CDSCO bars Global Pharma Healthcare from making eye lubricant

CDSCO bars Global Pharma Healthcare from making eye lubricant

Subject: Polity

Concept: National Body

• The Central Drugs Standard Control Organisation (CDSCO) has instructed Tamil Nadu-based Global Pharma Healthcare to stop manufacturing all the products under the category of ophthalmic preparation till the completion of an investigation.
• The move came soon after the U.S. Centres for Disease Control and Prevention (CDC) linked the company’s eye drops to 55 adverse events in the U.S.
• CDC have warned that the eye drops supplied by the company to distributors Aru Pharma/EzriCare and Delsam Pharma in the U.S. had been linked to adverse events, including eye infections, permanent loss of vision, and a death with a bloodstream infection.
• Raw material called carboxymethylcellulose sodium was used for manufacturing the eye lubricant.
• The company, which has recalled the eye drops from the market, has been placed on the FDA’s import alert list for allegedly providing an inadequate response to a records request.

Central Drugs Standard Control Organisation (CDSCO):

• The Central Drugs Standard Control Organisation (CDSCO) – under Directorate General of Health Services, Ministry of Health & Family Welfare.
• It is the National Regulatory Authority (NRA) of India.
• CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
• It regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940.
• Headquarters – New Delhi.

Major functions of CDSCO:

• Under the Drugs and Cosmetics Act, 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.