CDSCO asks state drug regulators to ‘keep a strong vigil’ on buclizine sales

CDSCO asks state drug regulators to ‘keep a strong vigil’ on buclizine sales

1. Central Drugs Standard Control Organisation (CDSCO) has issued an advisory to state drug regulators. It has asked them to keep monitoring on the manufacture, sale and distribution of buclizine. It is a brand of antihistamine and used as a motion sickness medicine.
2. This advisory came after it was found that a government order prohibiting the sale of buclizine as an appetite stimulant has not been followed and several batches of the drug continue to be sold without mandated disclaimers.
3. Earlier, the Health Ministry had issued an order stating that the use of buclizine as an appetite stimulant was likely to involve risk to human beings. It had also directed manufacturers to mention clearly on the drug’s package that it was not to be used as an appetite stimulant.
4. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device. It functions under the Drugs and Cosmetics Act, 1940. CDSCO comes under Directorate General of Health Services, Ministry of Health & Family Welfare.
5. CDSCO is responsible for (a) approval of New Drugs (b) Conduct of Clinical Trials (c) laying down the standards for Drugs (d) control over the quality of imported Drugs in the country and (e) coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.