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 Juvenile Justice (Care and Protection of Children) Bill, 2015 is currently pending in Rajya Sabha and was listed for passage in the current Winter session of Parliament.  The Bill was passed by Lok Sabha after incorporating certain amendments, in May 2015.  Here is all you need to know about the Bill and key issues associated with it.  A PRS analysis of the statistics on incidence of crimes by children and conviction rates is available here.

Table 1: Juveniles between 16-18 years apprehended under IPC  
Crime

2003

2013

Burglary

1,160

2,117

Rape

293

1,388

Kidnapping/abduction

156

933

Robbery

165

880

Murder

328

845

Other offences

11,839

19,641

Total

13,941

25,804

Note: Other offences include cheating, rioting, etc.  Sources: Juveniles in conflict with law, Crime in India 2013, National Crime Records Bureau; PRS.  

Who is a juvenile as recognised by law? In the Indian context, a juvenile or child is any person who is below the age of 18 years.  However, the Indian Penal Code specifies that a child cannot be charged for any crime until he has attained seven years of age. Why is there a need for a new Bill when a juvenile justice law already exists? The government introduced the Juvenile Justice Bill in August 2014 in Lok Sabha and gave various reasons to justify the need for a new law.  It said that the existing Juvenile Justice Act, 2000 was facing implementation issues and procedural delays with regard to adoption, etc.  Additionally, the government cited National Crime Records Bureau (NCRB) data to say that there has been an increase in crimes committed by juveniles, especially by those in the 16-18 years age group. NCRB data shows that the percentage of juvenile crimes, when seen in proportion to total crimes, has increased from 1% in 2003 to 1.2% in 2013.  During the same period, 16-18 year olds accused of crimes as a percentage of all juveniles accused of crimes increased from 54% to 66%.  However, the type of crimes committed by 16-18 year olds can be seen in table 1. What is the new Bill doing? Currently, the Juvenile Justice (Care and Protection of Children) Act, 2000 provides the framework to deal with children who are in conflict with law and children in need of care and protection.  The Bill seeks to replace the existing 2000 Act and lays down the procedures to deal with both categories of children.  It highlights the two main bodies that will deal with these children, to be set up in each district: Juvenile Justice Boards (JJBs) and Child Welfare Committees (CWCs).  It provides details regarding adoption processes and penalties applicable under the law.  The Bill provides for children between 16-18 years to be tried as adults for heinous crimes.  The three types of offences defined by the Bill are: (i) a heinous offence is an offence that attracts a minimum penalty of seven years imprisonment under any existing law, (ii) a serious offence is one that gets imprisonment between three to seven years and, (iii) a petty offence is penalized with up to three years imprisonment. Currently, how is a juvenile in conflict with law treated? How is that set to change? Under the 2000 Act, any child in conflict with law, regardless of the type of offence committed, may spend a maximum of three years in institutional care (special home, etc.)  The child cannot be given any penalty higher than three years, nor be tried as an adult and be sent to an adult jail.  The proposed Bill treats all children under the age of 18 years in a similar way, except for one departure.  It states that any 16-18 year old who commits a heinous offence may be tried as an adult.  The JJB shall assess the child’s mental and physical capacity, ability to understand consequences of the offence, etc.  On the basis of this assessment, a Children’s Court will determine whether the child is fit to be tried as an adult. What did the Standing Committee examining the Bill observe? One of the reasons cited for the introduction of the Bill is a spike in juvenile crime, as depicted by NCRB data.  The Standing Committee on Human Resource Development examining the Bill stated that NCRB data was misleading as it was based on FIRs and not actual convictions.  It also observed that the Bill violates some constitutional provisions and said that the approach towards juvenile offenders should be reformative and rehabilitative. The Bill as introduced posed certain constitutional violations to Article 14, 20(1) and 21.  These have been addressed by deletion of the relevant clause, at the time of passing the Bill in Lok Sabha. What does the United Nations Convention on the Rights of the Child (UNCRC) say? What are the obligations on the signatory nations? The UNCRC was ratified by India in 1992 and the 2000 Act was consequently brought in to adhere to the standards set by the Convention.  The proposed Bill maintains this aim and seeks to improve implementation and procedural delays experienced by the 2000 Act.  The UNCRC states that signatory countries should treat every child under the age of 18 years in the same manner and not try them as adults.  While the 2000 Act complies with this requirement, the Bill does not.  However, many other countries who have also ratified the Convention try juveniles as adults, in case of certain crimes.  These countries include the UK, France, Germany, etc.  The United States is not a signatory to the UNCRC and also treats juveniles as adults in case of certain crimes. Under the Bill, what happens to a child who is found to be orphaned, abandoned or surrendered? The Bill addresses children in need of care and protection.  When a child is found to be orphaned, abandoned or surrendered he is brought before a Child Welfare Committee within 24 hours.  A social investigation report is conducted for the child, and the Committee decides to either send the child to a children’s home or any other facility it deems fit, or to declare the child to be free for adoption or foster care.  The Bill outlines the eligibility criteria for prospective parents.  It also details procedures for adoption, and introduces a provision for inter-country adoption, so that prospective parents living outside the country can adopt a child in India. Currently, the Guidelines Governing Adoption, 2015 under the 2000 Act, regulates adoptions.  Model Foster Care Guidelines have also recently been released by the Ministry of Women and Child Development. What are the penalties for committing offences against children? Various penalties for committing offences against children are laid out in the Bill.  These include penalties for giving a child an intoxicating substance, selling or buying the child, cruelty against a child, etc. Issue to consider: The penalty for giving a child an intoxicating or narcotic substance is an imprisonment of seven years and a fine of up to one lakh rupees.  Comparatively, buying or selling a child will attract a penalty including imprisonment of five years and a fine of one lakh rupees. It remains to be seen if the Bill will be taken up for consideration in this session, and if its passage will address the issues surrounding children in conflict with the law.