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Regulation/Guidelines

Coronary Stents are Now Included in the National List of Essential Medicines: Its Impact on Prices, Availability, and Healthcare

  National List of Essential Medicines The National List of Essential Medicines (NLEM), 2011, has been reviewed and revised by the Core-Committee constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India. The committee has formulated a new list as per the inclusion and exclusion criteria. The […]

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Regulation/Guidelines

Import of Cosmetics Tested On Animal Prohibited

The central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945

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Regulation/Guidelines

First pill to prevent HIV is only for some patients

First pill to prevent HIV only for some patients to reduce new HIV cases.

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Regulation/Guidelines

Second Amendment in Drugs & Cosmetics Rule, 2013

In the Drugs and Cosmetics Rules, 1945, in Part X-A, after 122Dab, the following rule shall be inserted, namely

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Regulation/Guidelines

Faster Import of Human Biological Samples: No Prior Approval Required!

  As per the Director General of Foreign Trade (DGFT) via. the notification on August 4, 2016, (Notification No. 19 /2015-2020), an amendment in the policy of the import and export of biologicals used for commercial purposes has been made. This notification stated that the human biological samples used for […]

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Regulation/Guidelines

First amendment in Drugs & Cosmetics Rules 2013

In the Drugs and Cosmetics Rules, 1945, After rule 122DAA, the following rule shall be inserted, namely

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.

Regulation/Guidelines

Fourth Amendment in Drugs & Cosmetics Rules, 2013

Following are the rules to amend the Drugs & Cosmetics Rules, 1945, namely-These rules may be called the Drugs & cosmetics (Fourth Amendment) Rules, 2013

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