Petitions
- Petition to the Health Minister on confusing use of Crocin brand name
Resources:
- Comments on the proposed New Drugs, Cosmetics and Medical Devices Bill, 2022
Resources:
- Petition to the Health Minister proposing a new roadmap for India’s new drug regulatory law
Resources:
- Petition regarding the working of the Clinical Trial Registry of India
Resources:
- Saberwal G. The many uses of data in public clinical trial registries. Current Science. 2021;120: 6;
- Pillamarapu M, Mohan A, Saberwal G. An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India. Trials. 2019;20. doi:10.1186/s13063-019-3592-0
- Petition to ensure transparency in the investigation and recall of DEG contaminated cough syrup that killed 12 children
Resources:
- Media report from March, 2020 about the cough syrup killing 12 children;
- Media report from August 2020 on how a different brand of cough syrup manufactured by the same pharmaceutical company was suspected to be behind another case of renal failure of a 2 year old child;
- Judgment of the Himachal Pradesh High Court in petition filed by Digital Vision for restoration of its manufacturing licences;
- Petition to setup Expert Committee to examine the sampling and testing protocols of drugs withdrawn under Section 23 and Section 25 of the Drugs & Cosmetics Act, 1940
Resources:
- RTI replies from the Uttarakhand Health Department regarding samplying guidelines;
- RTI replies from the Commissioner, Gujarat Food & Drug Control Administration;
- RTI replies from the Joint Commissioner Maharashtra, Food and Drug Administration;
- RTI replies from the Office of the Drug Controller of Kerala;
- RTI replies from the Tamil Nadu Drug Control Administration;
- Comments on the Draft New Drugs and Clinical Trial (….Amendment) Rules, 2020
Resources:
- Petition to setup Expert Committee to amend the framework put in place by the Drugs & Cosmetics (Third Amendment) Rules, 2018 for stability testing of drugs
Resources:
- Annexure 1 – Guidance document provided by Ministry of Health in response to a RTI application;
- Annexure 2 – Draft IDMA Guidelines on stability testing (Courtesy – Pharmabiz);
- The Draft Drugs and Cosmetics (Second Amendment) Rules, 2015;
- The Drugs and Cosmetics (Third Amendment) Rules, 2018;
- Minutes of the 46th Meeting of the Drugs Consultative Committee Meeting held on the 12th and 13th of November, 2013;
- Minutes of the 65th Meeting of the Drugs Technical Advisory Board Meeting held on the 25th of November, 2013;
- Petition to setup Expert Committee to amend the bioequivalence framework put in place by the Drugs & Cosmetics (Ninth Amendment) Rules, 2017
Resources:
- Dr. Ranjit Roy Chaudhary Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs;
- Minutes of the 47th Meeting of the Drugs Consultative Committee Meeting held on July 30 & 31 of 2014;
- Minutes of the 72nd Meeting of the Drugs Technical Advisory Board held on June 27 of November, 2016;
- The Drugs and Cosmetics (Ninth Amendment) Rules, 2017;
- CDSCO notification on Reference Products for BE studies;
- USFDA Guidance on Bioequivalence/Bioavailability;
- USFDA Guidance on Biowaivers based on BCS;
- Comments on the proposed Drugs and Magic Remedies (Objectionable Advertisements) Amendment Bill 2020
Resources:
- Notice published by the Ministry of Health & Family Welfare inviting comments on the proposed amendments to the Drugs & Magic Remedies (Objectionable Advertisements);
- The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954;
- The amendments to Rule 170 of the Drugs & Cosmetics Rules, 1945 in 2018 by the Ministry of Ayush;
- Rajya Sabha Debates on the legislation in 1954
- Hamdard Dawakhana v. Union of India 1960 SCR (2) 671
- The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1963;
- Drugs & Magic Remedies (Objectionable Advertisements) Bill