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.

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:

  • Prohibition: The Bill imposes a prohibition on the manufacture, bottling, distribution, transportation, collection, storage, possession, sale and consumption of alcohol or any other intoxicant specified by the state government.  However, it also allows the state government to renew existing licenses, or allow any state owned company to undertake any of these activities (such as manufacture, distribution, etc.).
  • Excise revenue: The Bill expects to generate revenue from excise by levying (i) excise duty on import, export, manufacture, etc. of alcohol, (ii) license fee on establishing any manufactory, distillery, brewery, etc., (iii) fee on alcohol transit through Bihar, and (iv) fee on movement of alcohol within Bihar or import and export from Bihar to other states, among others.
  • Excise Intelligence Bureau: The Bill provides for the creation of an Excise Intelligence Bureau, which will be responsible for collecting, maintaining and disseminating information related to excise offences.  It will be headed by the Excise Commissioner.
  • Penalties and Offences: The Bill provides penalties for various offences committed under its provisions.  These offences include consuming alcohol, possession or having knowledge about possession of alcohol and mixing noxious substances with alcohol.  In addition, the Bill provides that if any person is being prosecuted, he shall be presumed to be guilty until his innocence is proven.
  • The Bill also allows a Collector to impose a collective fine on a group of people, or residents of a particular village, if these people are repeat offenders.

Process to be followed for offences The Bill outlines the following process to be followed in case an offence is committed:

  • If a person is found to have committed any offence under the Bill (such as consumption, storage or possession of alcohol), any authorised person (such as the District Collector, Excise Officer, and Superintendent of Police) may take action against the offender.
  • The Bill allows an authorised person to arrest the offender without a warrant.  Alcohol, any material or conveyance mode used for the offence may be confiscated or destroyed by the authorised person.  In addition, the premises where alcohol is found, or any place where it is being sold, may be sealed.
  • Under the Bill, the offender will be tried by a Sessions Court, or a special court set up by the state.  The offender may appeal against the verdict of the special court in the High Court.

Some issues that need to be considered

  • Family members and occupants as offenders: For illegal manufacture, possession or consumption of alcohol by a person, the Bill holds the following people criminally liable:
    1. Family members of the person (in case of illegal possession of alcohol). Family means husband, wife and their dependent children.
    2. Owner and occupants of a land or a building, where such illegal acts are taking place.

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.

  • Bar on Jurisdiction for confiscated items: The Bill allows for the confiscation of: (i) materials used for manufacturing alcohol, or (ii) conveyance modes if they are used for committing an offence (such as animal carts, vessels).  It provides that no court shall have the power to pass an order with regard to the confiscated property.  It is unclear what judicial recourse will be available for an aggrieved person.
  • Offences under the Bill: The Bill provides that actions such as manufacturing, possession or consumption of alcohol will attract an imprisonment of at least 10 years with a fine of at least one lakh rupees.  One may question if the term of imprisonment is in proportion to the offence committed under the Bill.

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.