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.

To contain the spread of COVID-19 in India, the central government imposed a nation-wide lockdown on March 24, 2020.  Under the lockdown most economic activities, other than those classified as essential activities, were suspended.  States have noted that this loss of economic activity has resulted in a loss of income for many individuals and businesses.  To allow some economic activities to start, some states have provided relaxations to establishments from their existing labour laws.  This blog explains the manner in which labour is regulated in India, and the various relaxations in labour laws that are being announced by various states. 

How is labour regulated in India?

Labour falls under the Concurrent List of the Constitution.  Therefore, both Parliament and State Legislatures can make laws regulating labour.  Currently, there are over 100 state laws and 40 central laws regulating various aspects of labour such as resolution of industrial disputes, working conditions, social security, and wages.  To improve ease of compliance and ensure uniformity in central level labour laws, the central government is in the process of codifying various labour laws under four Codes on (i) industrial relations, (ii) occupational safety, health and working conditions, (iii) wages, and (iv) social security.  These Codes subsume laws such as the Industrial Disputes Act, 1947, the Factories Act, 1948, and the Payment of Wages Act, 1936.   

How do state governments regulate labour?

A state may regulate labour by: (i) passing its own labour laws, or (ii) amending the central level labour laws, as applicable to the state.   In cases where central and state laws are incompatible, central laws will prevail and the state laws will be void.  However, a state law that is incompatible with central laws may prevail in that state if it has received the assent of the President.  For example: In 2014, Rajasthan amended the Industrial Disputes Act, 1947.  Under the Act, certain special provisions with regard to retrenchment, lay-off and closure of establishments applied to establishments with 100 or more workers.  For example, an employer in an establishment with 100 or more workers required permission from the central or state government prior to retrenchment of workers.  Rajasthan amended the Act to increase the threshold for the application of these special provisions to establishments with 300 workers.  This amendment to the central law prevailed in Rajasthan as it received the assent of the President. 

Which states have passed relaxations to labour laws?

The Uttar Pradesh Cabinet has approved an ordinance, and Madhya Pradesh has promulgated an ordinance, to relax certain aspects of existing labour laws.  Further, Gujarat, Rajasthan, Haryana, Uttarakhand, Himachal Pradesh, Assam, Goa, Uttar Pradesh, and Madhya Pradesh have notified relaxations to labour laws through rules.

Madhya Pradesh:  On May 6, 2020, the Madhya Pradesh government promulgated the Madhya Pradesh Labour Laws (Amendment) Ordinance, 2020.  The Ordinance amends two state laws: the Madhya Pradesh Industrial Employment (Standing Orders) Act, 1961, and the Madhya Pradesh Shram Kalyan Nidhi Adhiniyam, 1982.  The 1961 Act regulates the conditions of employment of workers and applies to all establishments with 50 or more workers.  The Ordinance increases this threshold to 100 or more workers.  Therefore, the Act will no longer apply to establishments with between 50 and 100 workers that were previously regulated.  The 1982 Act provides for the constitution of a Fund that will finance activities related to welfare of labour.  The Ordinance amends the Act to allow the state government to exempt any establishment or class of establishments from the provisions of the Act through a notification.  These provisions include payment of contributions into the Fund by employers at the rate of three rupees every six months. 

Further, the Madhya Pradesh government has exempted all new factories from certain provisions of the Industrial Disputes Act, 1947.  Provisions related to lay-off and retrenchment of workers, and closure of establishments will continue to apply.  However, the other provisions of the Act such as those related to industrial dispute resolution, strikes and lockouts, and trade unions, will not apply.   This exemption will remain in place for the next 1,000 days (33 months).  Note that the Industrial Disputes Act, 1947 allows the state government to exempt certain establishments from the provisions of the Act as long as it is satisfied that a mechanism is in place for the settlement and investigation of industrial disputes.

Uttar Pradesh

The Uttar Pradesh Cabinet has approved the Uttar Pradesh Temporary Exemption from Certain Labour Laws Ordinance, 2020.  According to news reports, the Ordinance seeks to exempt all factories and establishments engaged in manufacturing processes from all labour laws for a period of three years, subject to the fulfilment of certain conditions.  These conditions include:

  • Wages:  The Ordinance specifies that workers cannot be paid below minimum wage.  Further, workers must be paid within the time limit prescribed in the Payment of Wages Act, 1936.  The Act specifies that: (i) establishments with less than 1,000 workers must pay wages before the seventh day after the last day of the wage period and (ii) all other establishments must pay wages before the tenth day after the last day of the wage period.  Wages must be paid into the bank accounts of workers. 

  • Health and safety:   The Ordinance states that provisions of health and safety specified in the Building and Other Construction Workers Act, 1996 and Factories Act, 1948 will continue to apply.  These provisions regulate the usage of dangerous machinery, inspections, and maintenance of factories, amongst others. 

  • Work Hours:  Workers cannot be required to work more than eleven hours a day and the spread of work may not be more than 12 hours a day. 

  • Compensation:  In the case of accidents leading to death or disability, workers will be compensated as per the Employees Compensation Act, 1923. 

  • Bonded Labour: The Bonded Labour System (Abolition) Act, 1976 will continue to remain in force.  It provides for the abolition of the bonded labour system.   Bonded labour refers to the system of forced labour where a debtor enters into an agreement with the creditor under certain conditions such as to repay his or a family members debt, due to his caste or community, or due to a social obligation.  

  • Women and children:  Provisions of labour laws relating to the employment of women and children will continue to apply.  

It is unclear if labour laws providing for social security, industrial dispute resolution, trade unions, strikes, amongst others, will continue to apply to businesses in Uttar Pradesh for the period of three years specified in the Ordinance.  Since the Ordinance is restricting the application of central level labour laws, it requires the assent of the President to come into effect. 

Changes in work hours

The Factories Act, 1948 allows state governments to exempt factories from provisions related to work hours for a period of three months if factories are dealing with an exceptional amount of work.  Further, state governments may exempt factories from all provisions of the Act in the case of public emergencies.  The Gujarat, Himachal Pradesh, Rajasthan, Haryana, Uttar Pradesh, Goa, Assam and Uttarakhand governments passed notifications to increase maximum weekly work hours from 48 hours to 72 hours and daily work hours from 9 hours to 12 hours for certain factories using this provision.  Further, Madhya Pradesh has exempted all factories from the provisions of the Factories Act, 1948 that regulate work hours.  These state governments have noted that an increase in work hours would help address the shortage of workers caused by the lockdown and longer shifts would ensure fewer number of workers in factories allowing for social distancing to be maintained.   Table 1 shows the state-wise increase in maximum work hours. 

Table 1: State-wise changes to work hours

State

Establishments

Maximum weekly work hours

Maximum daily work hours

Overtime Pay (2x ordinary wages)

Time period

Gujarat

All factories

Increased from 48 hours to 72 hours 

Increased from 9 hours to 12 hours 

Not required

Three months

Himachal Pradesh

All factories

Increased from 48 hours to 72 hours 

Increased from 9 hours to 12 hours 

Required

Three months

Rajasthan

All factories distributing essential goods and manufacturing essential goods and food

Increased from 48 hours to 72 hours 

Increased from 9 hours to 12 hours 

Required

Three months

Haryana

All factories

Not specified  

Increased from 9 hours to 12 hours 

Required

Two months

Uttar Pradesh

All factories

Increased from 48 hours to 72 hours 

Increased from 9 hours to 12 hours 

Not required

Three months*

Uttarakhand

All factories and continuous process industries that are allowed to function by government

Maximum 6 days of work a week

Two shifts of 12 hours each.

Required

Three months

Assam

All factories

Not specified

Increased from 9 hours to 12 hours 

Required

Three months

Goa

All factories

Not specified

Increased from 9 hours to 12 hours 

Required

Approximately three months

Madhya Pradesh

All factories

Not specified

Not specified

Not specified

Three months

Note: *The Uttar Pradesh notification was withdrawn