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Marketing Authorization of Biological Products in India

What are Biological Products? Biological products are used for diagnosis, prevention, treatment and cure of diseases and certain medical conditions and are regulated by the Food and Drug Administration of India. They can be classified in varied categories and consist of complex molecules that are produced through biotechnological techniques in […]

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Clarification and requirements related to Post approval changes as per CDSCO Guidance for Industry for Biological Products

In order to update the Quality information of already licensed products in a systemic approach it has been decided to submit the updated PPD of all approved Biological Product on yearly basis having all changes compiled in Quality information.

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Regulation/Guidelines

Guidelines on “Similar Biologics: Regulatory requirements for Market Authorization in India” will be implemented from 15th September 2012.

The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.

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A Blueprint for Helping Children with Rare Diseases

The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children.

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DCGI to meet zonal officials to re-examine regulatory requirement for vaccines

DCGI has planned to meet senior officials from all the zonal offices across the country in the coming week to assess and examine the regulatory mechanism adopted for its vaccine manufacturing programme

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Self-Assessment/Audit of Unit for GMP/GLP Compliance

The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India being a major market for the healthcare-related products and its services, these modifications to the existing regulations are […]

Insight

Draft Guidelines on Similar Biologics, 2016

Medicinal products which are mainly composed of living tissues or cells are called Biologics

Insight

NDAC/MDAC/SEC

In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.

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