Mr. Vaghul, our first Chairperson, passed away on Saturday.  I write this note to express my deep gratitude to him, and to celebrate his life.  And what a life he lived!

Mr. Vaghul and I at his residence

 

 

 

 

 

 

 

Our past and present Chairpersons,
Mr. Vaghul and Mr. Ramadorai

Industry stalwarts have spoken about his contributions to the financial sector, his mentorship of people and institutions across finance, industry and non-profits.  I don’t want to repeat that (though I was a beneficiary as a young professional starting my career at ICICI Securities).  I want to note here some of the ways he helped shape PRS.

Mr Vaghul was our first chairman, from 2012 to 2018.  When he joined the board, we were in deep financial crisis.  Our FCRA application had been turned down (I still don’t know the reason), and we were trying to survive on monthly fund raise.  Mr Vaghul advised us to raise funds from domestic philanthropists.  “PRS works to make Indian democracy more effective.  We should not rely on foreigners to do this.”.  He was sure that Indian philanthropists would fund us.  “We’ll try our best.  But if it doesn’t work, we may shut down.  Are you okay with that?”  Of course, with him calling up people, we survived the crisis.

He also suggested that we should have an independent board without any representation from funders.  The output should be completely independent of funders’ interest given that we were working in the policy space.  We have stuck to this advice.

Even when he was 80, he could read faster than anyone and remember everything.  I once said something in a board meeting which had been written in the note sent earlier.  “We have all read the note.  Let us discuss the implications.”  And he could think three steps ahead of everyone else.

He had a light touch as a chairman.  When I asked for management advice, he would ask me to solve the problem on my own.  He saw his role as guiding the larger strategy, help raise funds and ensure that the organisation had a strong value system.  Indeed, he was the original Karmayogi – I have an email from him which says, “Continue with the good work.  We should neither be euphoric with appreciation or distracted by criticism.” And another, "Those who adhere to the truth need not be afraid of the consequences".

The best part about board meetings was the chat afterwards.  He would have us in splits with stories from his experience.  Some of these are in his memoirs, but we heard a few juicier ones too!

Even after he retired from our Board, he was always available to meet.  I just needed to message him whenever I was in Madras, and he would ask me to come home.  And Mrs. Vaghul was a welcoming host.  Filter coffee, great advice, juicy stories, what more could one ask for?

Goodbye Mr. Vaghul.  Your life lives on through the institutions you nurtured.  And hope that we live up to your standards.

Madhavan

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.