All posts tagged: Drugs and Cosmetics Act

Centre bans 16 fixed-dose drug combinations citing public health concerns

Centre bans 16 fixed-dose drug combinations citing public health concerns

The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack “therapeutic justification” and their continued use was not considered beneficial in relation to the potential risks involved. The Ministry banned the FDC in the notifications issued under Section 26A of the Drugs and Cosmetics Act, 1940. (Representational Photo/Unsplash) The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public. Also Read| Spl campaign against drugs to be launched across 441 panchayats in Shimla: Kashyap FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The decision follows a review of FDCs undertaken in compliance with the Supreme Court’s directions. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful. “The manufacture for sale, sale, distribution and supply of the identified …

CDSCO modifies norms for testing permissions to speed up drug approvals| India News

CDSCO modifies norms for testing permissions to speed up drug approvals| India News

New Delhi, In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny. CDSCO modifies norms for testing permissions to speed up drug approvals In an official circular, the country’s apex drug regulatory authority, Central Drugs Standard Control Organization , said it has decided that “No Objection Certificate for testing of drug samples at the designated laboratories shall be issued immediately upon receipt of applications in the concerned division.” Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing. These included “Type of formulation, dosage form, Critical Quality Attributes , and general characteristics of the product,” along with “Product development reports, forced degradation studies, and other relevant data, in accordance with applicable guidelines,” compliance with pharmacopoeial monographs, and provisions of the Drugs and Cosmetics Act, 1940. Testing is a mandatory prerequisite before approval and is conducted at government laboratories, including the Indian Pharmacopoeia Commission , …