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.

As of April 17, Madhya Pradesh has 1,120 confirmed cases of COVID-19 - the fifth-highest among all states in India.  The Government of Madhya Pradesh issued one of its initial COVID-19 related orders around January 28, 2020, advising healthcare workers to use appropriate protective gear when examining patients from Wuhan, China.   Since then, the government has taken several actions to contain the spread and impact of COVID-19.  In this blog, we look at key measures taken so far.

Figure 1: Day-wise COVID-19 cases in Madhya Pradesh

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Early stages: Focus on screening international travellers

On January 28, the state government issued directions to monitor international travellers from specified countries, test and maintain surveillance on those who are symptomatic.  A further order required district administrators to monitor and report on all passengers who arrived from China between December 31, 2019 and January 29, 2020.  While efforts were largely focused on screening and testing, the first quarantine restrictions for symptomatic travellers from China, entering India after January 15, were imposed on January 31.  Those leaving quarantine were subsequently kept under surveillance and their health conditions reported on for a period of 14 days.  By February 13, a constant presence of a medical team at the airport was required to test foreign passengers from an increasing list of countries and send daily reports.  

February and early March: Improving public health capacity, restricting social gatherings

The next steps from the government were aimed towards adapting the public health infrastructure to handle the evolving situation.  Following are some of the steps taken in this regard:

  • A helpline, with a dedicated call centre, was set up to inform citizens about COVID-19 and its prevention.
  • The regional directors of the Directorate of Health Services, Government of Madhya Pradesh, were instructed to ensure availability of N-95 masks and PPE kits in their region.
  • The Health Department issued guidelines to the Chief Medical and Health Officials in the State regarding the collection and transport of COVID-19 test samples.
  • Medical professionals in public hospitals were ordered to attend a national training.
  • An order was issued to improve arrangements for quarantine and isolation wards.
  • Leaves were cancelled for all employees/officers of the Health Department. 
  • To grant certain rights to establish effective control over outbreak affected areas and take swift actions, section 71 of the Madhya Pradesh Public Health Act, 1949 was invoked.  This section of the Act provides all Chief Medical and Health Officers and Civil Surgeon cum Chief Hospital Superintendents rights set out therein.  

As the number of cases in India increased through March, the MP government turned focus and issued orders directly concerning their citizens.   Several measures were undertaken to spread awareness about COVID-19 and implement social distancing.  

  • dedicated portal was created for COVID-19 related information.  
  • An order was issued to close several establishments including schools, colleges, cinema halls, gyms and swimming pools.  Biometric attendance was stopped at all government workplaces. 
  • On March 20, the government issued an order (effective till June 15) requiring suppliers of masks and sanitizers to: (i) maintain a fixed price and (ii) keep and present fortnightly, a record of purchase and sales of the essential items.  The order also prevented them from refusing to sell to any customer. 

March 21 Onwards

On March 21, MP reported four cases of COVID-19. On March 23, the government released the Madhya Pradesh Epidemic Diseases, COVID-19 Regulations 2020 to prevent the spread of COVID-19 in the state.  These regulations specify special administrative powers and protocol for hospitals (government and private) to follow while treating COVID-19 patients. These regulations are valid for one year. Over and above general instructions to maintain social distancing and personal hygiene, the government has undertaken specific measures to: (i) increase healthcare capacity, (ii) institute welfare protection for the economically vulnerable population, (iii) strengthen the administrative structure and data collection, and (iv) ensure supply of essential goods and services.  These measures include-

Healthcare measures

  • Preparation of hospitals for the treatment of COVID-19 including postponing elective surgeries, ensuring an adequate supply of PPE kits. 
  • On March 28, the Bhopal Memorial Hospital and Research Centre was designated as a state-level COVID-19 hospital.  This order was reversed on April 15. 
  • District collectors were empowered to appoint doctors and other healthcare workers as required in their districts in a fast-tracked manner.
  • Establishing a telemedicine unit in each of the 51 district hospitals
  • Facilitating the appointment of final year undergraduate nursing students as nurses
  • On March 29, the government launched the SAARTHAK app for daily monitoring and tracking of quarantined and corona positive patients
  • The government released a strategy document to contain COVID-19. This strategy places emphasis on identification of suspected cases, isolation, testing of high-risk contacts, and treatment (called the I. I. T. T. strategy)

Welfare measures

  • One-time financial assistance of Rs 1,000 will be provided to construction labourers
  • One-time financial assistance of Rs 2,000 will be provided to families of Sahariya, Baiga and Bharia tribes
  • Social security pensions for two months will be paid in advance to pensioners
  • People without eligibility slips under the National Food Security Scheme to be allowed to receive ration 

Administrative measures

  • Senior officials were designated to coordinate with various states to resolve issues regarding migrant labour.
  • District Crisis Management groups were formed to coordinate state-level policy and the local implementation machinery.

Supply of essential goods and services

  • On April 8, the government implemented the Essential Services Management Act,1979. The Act among other things, prohibits anyone employed in essential services to refuse to work.
  • E-pass procurement facility was started to ensure smooth inter-district and across states flow of essential goods & services.  

For more information on the spread of COVID-19 and the central and state government response to the pandemic, please see here.