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 13, 2020, there are 9,152 confirmed cases of COVID-19 in India.  Of these, 857 patients have been cured/discharged and 308 have died.  As the spread of COVID-19 has increased across India, the central government has continued to announce several policy decisions to contain the spread, and support citizens and businesses who are being affected by the pandemic.  In this blog post, we summarise some of the key measures taken by the central government in this regard between April 7 and April 13, 2020. 

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Source: Ministry of Health and Family Welfare, PRS.

Health

Supreme Court orders free testing for COVID-19 and provision of personal protective equipment for healthcare workers

  • Free testing for COVID-19: The Supreme Court held that COVID-19 tests should be free of cost for persons belonging to economically weaker sections as notified by the government and those covered under the Ayushman Bharat scheme, irrespective of whether they are conducted in private or public laboratories. Further, it held that COVID-19 tests may only be carried out in laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories, or any agencies approved by the World Health Organisation or Indian Council for Medical Research.  Prior to this order, tests were free of cost in government laboratories.  However, private laboratories were permitted to charge up to Rs 4,500 per test.  

  • Personal protective equipment for healthcare workers: The Supreme Court held that availability of appropriate personal protective equipment (PPE) for front line healthcare workers must be ensured by the government.  PPE includes gloves, masks, goggles, face shields, and shoe covers. Usage of PPE must be based on guidelines provided by the Ministry of Health and Family Welfare and the World Health Organisation.   Further, it directed the government to promote domestic production of PPE by means such as allowing movement of raw material.  Restriction on exports of PPE may also be instituted.
     

  • Security for healthcare workers: The Court also noted that healthcare workers treating COVID-19 patients were facing violence by the public due to stigma associated with their potential exposure to COVID-19.  The Court held that states and union territories should direct police authorities to provide security to doctors and medical staff in hospitals, places where persons have been quarantined, and while conducting screening visits.  Necessary action must be taken against persons who obstruct and commit any offence in respect to performance of duties by doctors, medical staff and other government officials working to contain the outbreak of COVID-19. 

Exemptions from customs duty and health cess for certain items

The central government has exempted the levy of basic customs duty and health cess on certain items.  These include ventilators, face masks, PPE, COVID-19 testing kits, and items necessary to manufacture these items.  The exemptions will remain in force until September 30, 2020.

Financial Assistance 

COVlD-19 emergency response and health system preparedness package

The central government approved the COVlD-19 emergency response and health system preparedness package.  It will be implemented in three phases from January 2020 to March 2024.  The objectives of the package include: (i) strengthening national and state health systems, (ii) support preparedness for COVID-19, (iii) procure essential medical equipment and drugs, (iv) setting up laboratories for surveillance, and (v) biosecurity. 

The Ministry of Health and Family Welfare has initiated release of funds for phase 1 of the programme which will last until June 2020.  These funds will be utilised for activities such as: (i) developing hospitals and isolation wards for COVID-19 patients, (ii) providing ventilators, (iii) expansion of diagnostic capacities, and (iv) community surveillance for the disease.  

Permission granted for partial withdrawal from National Pension System

Subscribers of the National Pension System may make partial withdrawals to fulfil their financial needs.   Withdrawals will be permitted on formal request by the subscriber.  Funds may be utilised for the treatment of the illness of a subscriber, his spouse, children (including adopted children), or dependent parents.

All pending income tax refunds up to five lakh rupees to be issued 

To provide immediate relief to businesses and individuals, all pending income-tax refunds up to five lakh rupees, will be issued immediately.  This is estimated to benefit approximately 14 lakh taxpayers.  Further, all pending GST and Customs refunds will be issued.  This will benefit around one lakh business entities.  The total refund granted will be approximately Rs 18,000 crore.

Compensation for Food Corporation of India Employees in case of death due to COVID-19

The central government has approved the proposal for monetary compensation to 1.08 lakh workers of the Food Corporation of India (FCI) including 80,000 labourers who are working to supply food grains across the country. Currently, families of FCI employees are entitled to compensation in the event of death due to terrorist attack, bomb blast, mob attack or natural disaster.  However, the regular and contractual labour of FCI are not covered. Under this proposal, all workers on duty will be insured in the event of death due to COVID-19 between March 24, 2020 and 23 September, 2020.  Regular labour will be entitled to 15 lakh rupees, contractual labour will be entitled to 10 lakh rupees, category 1 officers will be entitled to 35 lakh rupees, category 2 officers will be entitled to 30 lakh rupees, and category 3 and 4 workers will be entitled to 25 lakh rupees.

NGOs permitted to buy food grains directly from FCI for relief operations

The government noted that NGOs and charitable organisations are playing an important role in providing food to thousands of poor people during the lockdown.  To ensure uninterrupted supply of food grain to these organisations, the central government has directed FCI to provide wheat and rice to NGOs at the Open Market Sale Scheme rate.  These rates are generally reserved for state governments and registered bulk users.  This implies that these organisations can purchase one to ten metric tonnes of wheat and rice at a time from FCI at the predetermined reserve prices. 

Increasing financial resources

Reduction in salaries and benefits to Members of Parliament

The centre issued two Ordinances to amend: (i) the Salary, Allowances, and Pension of Members of Parliament Act, 1954 to reduce the salaries of MPs by 30% for a period of one year, and (ii) the Salaries and Allowances of Ministers Act, 1952, to reduce the sumptuary allowance of Ministers by 30% for one year.  The government also amended the rules notified under the 1954 Act to reduce certain allowances of MPs for one year, and suspended the MPLAD Scheme for two years. The MPLAD scheme enables members of parliament to recommend developmental work in their constituencies.  These changes are being made to supplement the financial resources of the centre to tackle the COVID-19 pandemic. The proposed reduction to the salaries and allowances of MPs and Ministers amounts to savings of around Rs 55 crore, and the suspension of the MPLAD scheme is expected to save Rs 7,800 crore.  These measures comprise 0.03% and 4.5% respectively, of the estimated amount required to fight the immediate economic distress unleashed due to COVID.

For more information on the implications of the reduction of salaries and benefits to MPs, please see here

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