1.  Is the government empowered to intercept communication between two individuals? Answer: Yes. The Central and the State government can intercept communication.  Letters, telephone (mobiles and landlines) and internet communication (e mails, chats etc.) can be intercepted by the government. Interception of:

  • postal articles is governed by the Indian Post Office Act, 1898 [Section 26];
  • telephones is governed by the Indian Telegraph Act, 1885 [Section 5(2)];
  • e mails/chats etc. is governed by the Information Technology Act, 2000 [Section 69].

2. Under what circumstances can the government intercept communication? Answer: The circumstances under which communication can be intercepted by the government are:

  • for postal articles: the occurrence of any public emergency, or in the interest of the public safety or tranquility;
  • for telephones: in the interests of the sovereignty and integrity of India, the security of the State, friendly relations with foreign States or public order or for preventing incitement to the commission of an offence;
  • for e mails / chats etc.: in the interests of the sovereignty and integrity of India, the security of the State, friendly relations with foreign States, or public order or for preventing incitement to the commission of any cognizable offence relating to above;

3. Are there any safeguards that have been built into the interception process? Answer: The Supreme Court in the case of PUCL Vs Union of India observed that the right to have telephone conservation in the privacy of one’s home or office is part of the Right to Life and Personal Liberty enshrined in Article 21 of the Constitution, which cannot be curtailed except according to the procedure established by law. Elaborating the scope of Section 5 (2) of the Indian Telegraph Act, 1882 the Court clarified that this section does not confer unguided and unbridled power on investigating agencies to invade a person’s privacy. The court laid down the following safeguards: a.  Tapping of telephones is prohibited without an authorizing order from the Home Secretary, Government of India or the Home Secretary of the concerned State Government b. The order, unless it is renewed shall cease to have authority at the end of two months from the date of issue. Though the order may be renewed, it cannot remain in operation beyond six months. c. Telephone tapping or interception of communications must be limited to the address (es) specified in the order or to address (es) likely to be used by a person specified in the order. d. All copies of the intercepted material must be destroyed as soon as their retention is not necessary under the terms of Section 5 (2) of the Indian Telegraph Act, 1882. e. In an urgent case, this power may be delegated to an officer of the Home Department, Government of India or the Home Department of the State government, who is not below the rank of Joint Secretary. Copy of this order should be sent to the concerned Review Committee within one week of passing of the order. f. This Review Committee shall consist of the Cabinet Secretary, Law Secretary and the Secretary Telecommunications at the Central Government. At the state level, the Committee shall comprise of Chief Secretary, Law Secretary and another member (other than the Home Secretary) appointed by the State Government. The Committee shall on its own, within two months of the passing of an order under Section 5 (2) investigate whether its passing is relevant. If an order is in existence, the Committee should find out whether there has been a contravention of the provisions of Section 5 (2). If the Review Committee on investigation concludes that provisions of Section 5 (2) have been contravened, it shall direct destruction of the copies of the intercepted material. In pursuance of the Supreme Court judgement the Indian Telegraph (First Amendment) Rules, 1999 were framed and notified on 16.02.1999. A similar notification titled, the Information Technology (Procedures and Safeguards for Interception, Monitoring and Decryption of Information Rules, 2009 were notified on October 27, 2009. [see page 18] 4. Are there any other known cases of telephone tapping of politicians? Answer: In 2005, Shri Amar Singh alleged that his telephones were tapped by private individuals.  The case against them is currently pending in the Tis Hazari court in Delhi. 5. Are there any statistics about the number of telephones being tapped by the government? Answer:  Currently no such statistics are publicly available.  In a similar context, in the UK (where the Regulation of Investigatory Powers Act 2000 governs this particular subject) a Report of the Interception of Communications Commissioner states that a total of 5344 warrants were issued for interception of communication in 2008.

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:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

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:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.