On June 6, 2022, the Ministry of Electronics and Information Technology released the draft amendments to the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021 (IT Rules, 2021) for public feedback. The IT Rules were notified on February 25, 2021, under the Information Technology Act, 2000 (IT Act). The Ministry noted that there is a need to amend the Rules to keep up with the challenges and gaps emerging in an expanding digital ecosystem. In this blog post, we give a brief background to the IT Rules, 2021 and explain the key proposed changes to the Rules.
Background to the IT Rules, 2021
The IT Act exempts intermediaries from liability for user-generated content on their platform provided they meet certain due diligence requirements. Intermediaries are entities that store or transmit data on behalf of other persons and include telecom and internet service providers, online marketplaces, search engines, and social media sites. IT Rules specify the due diligence requirements for the intermediaries. These include: (i) informing users about rules and regulations, privacy policy, and terms and conditions for usage of its services, including types of content which are prohibited, (ii) expeditiously taking down content upon an order from the government or courts, (iii) providing a grievance redressal mechanism to resolve complaints from users about violation of Rules, and (iv) enabling identification of the first originator of the information on its platform under certain conditions. It also specifies a framework for content regulation of online publishers of news and current affairs and curated audio-visual content. For an analysis of the IT Rules 2021 please see here.
Key changes proposed to the IT Rules 2021
Key changes proposed by the draft amendments are as follows:
Comments on the draft amendments are invited until July 6, 2022.
The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO). CDSCO is the agency mandated with the regulation of drugs and cosmetics in India. The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation. The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO. It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules]. The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import. State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:
The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy. These trials are necessary for both domestically manufactured and imported drugs. However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws. Following are some of the Report’s findings:
