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Draft of New Regulations for Clinical Trials in India Favours Drug Development in the Country

  The Ministry of Health and Family Welfare has come with new regulations regarding clinical trials of drugs in India called New Drugs and Clinical Trials Rules, 2019 with the objective to make the country more favourable for clinical research and drug development. These new rules will apply to all […]

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Insight

Subject Expert Committee’s Updates

The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is the Central Drug Authority for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act. […]

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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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Insight

Kokate Committee

Constitution: The Kokate Committee was constituted by Ministry Of Health And Family Welfare, Government of India, under the chairmanship of Prok. C.K. Kokate, VC, KLE University, Belgaum, Karnataka.(1) The need to constitute the Kokate Committee: Drug Controller General India (DCGI) had issued a letter dated 15.01.2013 to all the State […]

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Strategy

Global Licensing & Registration

Drug product registration and licensing in Europe, Africa, Asia, the Middle East and South America

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News

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

India Champions e-Governance for Pharma Industry

National e-Governance plan (NeGP), launched in 2006 as initiative that Government of India has implemented to make all government services accessible online.

Insight

Sugam – CDSCO Portal for Online Application

Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015

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