CASEM

Reforming the sampling and testing protocols under the Drugs & Cosmetics Act

Continuing with our campaign to improve the quality of drugs in India, we recently sent another petition to the Ministry of Health asking for a relook at the sampling and testing protocols followed by Drug Inspectors and Government Analysts under the Drugs & Cosmetics Act, 1940. The petition can be accessed here. The Drugs & …

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The proposed regulatory pathway for ‘emergency use’ authorization of new drugs

Last month, the Ministry of Health invited comments on a proposed amendment to the New Drugs and Clinical Trial Rules, 2019 in order to create a new regulatory pathway for patients in private hospitals to access unapproved experimental drugs under a new compassionate use policy. The existing rules already provide for such a pathway to …

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A petition to reform the legal framework for bioequivalence testing requirements for generic drugs

Continuing with our campaign to improve the quality of generic medicines made in India, we filed one more petition with the Minister of Health on the issue of bioequivalence testing for new generic drugs being approved in India. The petition can be accessed over here. The simple aim of bioequivalence testing is to ensure that …

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A petition to relook the legal framework governing stability testing of drugs in India

We recently sent a petition requesting it to reexamine the entire legal framework surrounding stability testing of generic drugs in India to the Ministry of Health. The issue of stability testing is critical in guaranteeing that only medicines of standard quality reach patients. This is because most drugs, which are combination of chemical substances (and …

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The proposed amendments to the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954

A few months ago, the Ministry of Health and Family Welfare announced that it was planning to amend the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954. A draft of the amendments was published along with the notice and comments were invited from the general public. It has become quite rare for government to conduct …

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