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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:
The Bihar Prohibition and Excise Bill, 2016 was introduced and debated in the Bihar Legislative Assembly today. The Bill creates a framework for the levy of excise duty and imposes a prohibition on alcohol in Bihar. In this context, we examine key provisions and some issues related to the Bill. Prohibition on the manufacture, sale, storage and consumption of alcohol was imposed in Bihar earlier in 2016, by amending the Bihar Excise Act, 1915. The Bill replaces the 1915 Act and the Bihar Prohibition Act, 1938. Key features of the Bill include:
Process to be followed for offences The Bill outlines the following process to be followed in case an offence is committed:
Some issues that need to be considered
The Bill presumes that the family members, owner and occupants of the building or land ought to have known that an illegal act is taking place. In all such cases, the Bill prescribes a punishment of at least 10 years of imprisonment, and a fine of at least one lakh rupees.
These provisions may violate Article 14 and Article 21 of the Indian Constitution. Article 14 of the Constitution provides that no person will be denied equality before law. This protects individuals from any arbitrary actions of the state.[1] It may be argued that imposing criminal liability on (i) family members and (ii) owner or occupants of the building, for the action of another person is arbitrary in nature.
Article 21 of the Constitution states that no person can be deprived of their life and personal liberty, except according to procedure established by law. Courts have interpreted this to mean that any procedure established by law should be fair and reasonable.[2] It needs to be examined whether presuming that (i) family members of an offender, and (ii) owner or occupant of the building knew about the offence, and making them criminally liable, is reasonable.
Note that under the Indian Penal Code, 1860 an imprisonment at least 10 years is attracted in crimes such as use of acid to cause injury, or trafficking of a minor. Other states where a prohibition on alcohol is imposed provide for a lower imprisonment term for such offences. These include Gujarat (at least seven years) and Nagaland (maximum three years).[3]
Note: At the time of publishing this blog, the Bill was being debated in the Legislative Assembly. [1] E.P. Royappa v State of Tamil Nadu, Supreme Court, Writ Petition No. 284 of 1972, November 23, 1973. [2] Maneka Gandhi v Union of India, AIR 1978 SC 597. [3] Gujarat Prohibition Act, 1949, http://www.prohibition-excise.gujarat.gov.in/Upload/06asasas_pne_kaydaao_niyamo_1.pdf.