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 Lok Sabha has passed the bill to revise the salary of members of parliament. Much of the debate in the media has been on the wealth of current MPs and the lack of accountability. It is important to focus as well on structural issues related to remunerating legislators. Under the bill, the base salary of MPs is being raised to Rs.50,000 from Rs.16,000 per month. The daily allowance paid to MPs when they attend parliament is being hiked to Rs.2,000 from Rs.1,000. The constituency allowance is being increased to Rs.45,000 per month from Rs.20,000 and office expenses (for staff, stationery and postage) to Rs.45,000 per month from Rs.20,000. Pension for former MPs will be Rs.20,000 per month instead of the present Rs.8,000. Other than these, MPs get accommodation in Delhi, which varies from a hostel in Vitthalbhai Patel House to two-bedroom flats and bungalows, all in central Delhi. MPs get reimbursement of electricity, water, telephone and internet charges. They (and their family) are also reimbursed for 34 one-way air tickets from their constituency to Delhi. In a parliamentary democracy, compensation for legislators should be sufficient to ensure their independence and autonomy. It should attract professionals who can devote their full time to legislative work. There should be a sufficient support system to enable legislators perform their duties effectively. There are mainly three issues that need to be resolved while fixing the compensation package for legislators. First, MPs fix their own salaries and allowances, which results in a conflict of interest. Second, every time the salary is revised upwards, there is an adverse media and public reaction. The outcome is that MPs' salaries are significantly lower than that for any other position of similar responsibility in the public or private sector. The low salaries may deter honest persons, without other income sources, from contesting elections. Third, reimbursements of office expenses are classified as 'allowances'. Thus, expenses for office staff, telephone charges, etc. are often seen as part of their compensation. Contrast this with the treatment for government or private sector employees. The costs of office support staff, rental, communication and travel costs are not counted as their salary or perks. The process in India is similar to that in some countries. The US Congress and the German Bundestag determine their own salaries. There are two alternative approaches seen in some other democracies. Some countries appoint an independent authority to determine salaries. Some others peg the salary to that of public officials. For example, New Zealand has a remuneration tribunal which is tasked to fix salaries based on being (a) fair relative to levels of remuneration elsewhere; (b) fair to person being remunerated and the taxpayer; (c) adequate to recruit and retain competent persons. In Canada, a commission is appointed after every general election and salaries are then indexed to the federal government's annual wage rate index. Australia has a remuneration authority that links the salary to that in the Principal Executive Office. In the UK, the Senior Salaries Review Board determines salaries, which are then voted upon by parliament. The Scottish parliament indexes its salaries to that of British MPs. In France, the salary of the legislator is the average of the highest and lowest paid official in the seniormost level of the government. There were two distinct themes during last week's Lok Sabha debate. Several MPs discussed structural issues. Some MPs - L.K. Advani, Ramachandra Dome, Sanjay Nirupam, Shailendra Singh and Pinaki Misra - suggested that the government establish an independent commission for determining salaries. Advani pointed out that a decision to that effect had been taken in an all-party meeting held by the Speaker in may 2005 and demanded that the government announce the formation of such a commission before the end of the current session of parliament. Some MPs - Dhananjay Singh, Sanjay Nirupam and Shailendra Kumar -- focussed on the need for support structures such as office space, research staff and assistants in the constituency. They felt that these would help MPs examine proposed laws and rules and monitor the work of the government. Nirupam and Misra suggested that MPs' salaries be linked to performance; salaries should be cut for any time lost due to disruption. Some MPs highlighted the need for pension and accommodation for former MPs. Sharad Yadav, Raghuvansh Prasad Singh and Sansuma Khunggur Bwiswmuthiary requested that the pension be raised to Rs 25,000 per month. Yadav and Bwiswmuthiary also said that former MPs be allocated residential accommodation in Delhi. The bill will next be discussed in the Rajya Sabha. The government agreed that there is merit in forming an independent commission. It is however uncertain whether the government will accede to Advani's demand that the commission be announced in the next couple of days. - M.R. Madhavan This column has been published by IANS today.