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On 5th May, the High Court of Himachal Pradesh in an astonishing judgment delivered in the case of Salus Pharmaceuticals v. Union of India ruled that drug inspectors of the Central Drugs Standard Control Organisation (CDSCO) – the country’s national drug regulator – cannot conduct inspections or launch prosecutions of pharmaceutical companies under the Drugs & Cosmetics Act, … Of the judiciary and drug quality
A few weeks ago, the Citizens Generic v. Branded Drugs Project sponsored and designed by the Mission of Ethics and Science in Healthcare (MESH) announced on social media, astonishing results of its study that tested 131 generic drugs before peer-review was completed. MESH has now made public the test reports for all 131 generic drugs, … More questions about the MESH study on quality of generics sold in India
Over the last few years, multiple controversies have erupted over the legality and ethics of advertising campaigns in English language newspapers, launched by companies manufacturing Ayurvedic products. These sellers often claims that their products can treat a wide range of diseases like cancer and diabetes. Little attention however has been paid to the digital space … Big Tech’s disregard for drug advertising laws in India
We recently sent a petition to the Ministry of Health & Family Welfare with regard to the ongoing process to draft a new Drugs, Cosmetics and Medical Devices Act. It is not clear whether the committee setup to draft this new law is even conducting public consultations. In our petition we made specific recommendations for … A petition proposing a new roadmap for India’s new drug regulatory law
We recently sent a petition to the Ministry of Health and Family Welfare, urging them to improve the processes which govern the conduct of clinical trials in India. The setting up of the Clinical Trials Registry in India (“Registry”) in 2007 has lent a degree of transparency to the conduct of clinical trials in India. … Petition to improve the conduct of clinical trials in India by improving the functioning of the Clinical Trials Registry
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 & … Reforming the sampling and testing protocols under the Drugs & Cosmetics Act
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 … The proposed regulatory pathway for ‘emergency use’ authorization of new 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 … A petition to reform the legal framework for bioequivalence testing requirements for generic drugs
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 … A petition to relook the legal framework governing stability testing of drugs in India
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 … The proposed amendments to the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954