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.

This blog has been updated on Jan 19, 2021 to also cover the Madhya Pradesh Ordinance which was promulgated earlier in the month. The comparison table has also been revised accordingly.

On November 27, 2020, the Uttar Pradesh (UP) Prohibition of Unlawful Conversion of Religion Ordinance, 2020 was promulgated by the state government. This was followed by the Madhya Pradesh (MP) government promulgating the Madhya Pradesh Freedom of Religion Ordinance, 2020, in January 2021. These Ordinances seek to regulate religious conversions and prohibit certain types of religious conversions (including through marriages). The MP Ordinance replaces the MP Dharma Swatantra Adhiniyam, 1968, which previously regulated religious conversions in the state. Few other states, including Haryana and Karnataka, are also planning to introduce a similar law.  This blog post looks at existing anti-conversion laws in the country and compares the latest UP and MP Ordinances with these laws.

Anti-conversion laws in India

The Constitution guarantees the freedom to profess, propagate, and practise religion, and allows all religious sections to manage their own affairs in matters of religion; subject to public order, morality, and health.  To date, there has been no central legislation restricting or regulating religious conversions. Further, in 2015, the Union Law Ministry stated that Parliament does not have the legislative competence to pass anti-conversion legislation. However, it is to be noted that, since 1954, on multiple occasions, Private Member Bills have been introduced in (but never approved by) the Parliament, to regulate religious conversions. 

Over the years, several states have enacted ‘Freedom of Religion’ legislation to restrict religious conversions carried out by force, fraud, or inducements.  These are: (i) Odisha (1967), (ii) Madhya Pradesh (1968), (iii) Arunachal Pradesh (1978), (iv) Chhattisgarh (2000 and 2006), (v) Gujarat (2003), (vi) Himachal Pradesh (2006 and 2019), (vii) Jharkhand (2017), and (viii) Uttarakhand (2018). Additionally, the Himachal Pradesh (2019) and Uttarakhand legislations also declare a marriage to be void if it was done for the sole purpose of unlawful conversion, or vice-versa. Further, the states of Tamil Nadu (2002) and Rajasthan (2006 and 2008) had also passed similar legislation.  However, the Tamil Nadu legislation was repealed in 2006 (after protests by Christian minorities), while in case of Rajasthan, the bills did not receive the Governor’s and President’s assent respectively.  Please see Table 2 for a comparison of anti-conversion laws across the country.  

In November 2019, citing rising incidents of forced/fraudulent religious conversions, the Uttar Pradesh Law Commission recommended enacting a new law to regulate religious conversions. This led the state government to promulgate the recent Ordinance in 2020. Following UP, the MP government also decided to promulgate an Ordinance in January 2021 to regulate religious conversions. We discuss key features of these ordinances below. 

What do the UP and MP Ordinances do?

The MP and UP Ordinances define conversion as renouncing one’s existing religion and adopting another religion. However, both Ordinances exclude re-conversion to immediate previous religion (in UP), and parental religion (in MP) from this definition. Parental religion is the religion to which the individual’s father belonged to, at the time of the individual’s birth. These Ordinances prescribe the procedure for individuals seeking to undergo conversions (in the states of UP and MP) and declare all other forms of conversion (that violate the prescribed procedures) illegal.  

Procedure for conversion: Both the Ordinances require: (i) persons wishing to convert to a different religion, and (ii) persons supervising the conversion (religious convertors in UP, and religious priests or persons organising a conversion in MP) to submit an advance declaration of the proposed religious conversion to the District Magistrate (DM). In both states, the individuals seeking to undergo conversion are required to give advance notice of 60 days to the DM. However, in UP, the religious convertors are required to notify one month in advance, whereas in MP, the priests or organisers are also required to notify 60 days in advance. Upon receiving the declarations, the DMs in UP are further required to conduct a police enquiry into the intention, purpose, and cause of the proposed conversion. No such requirement exists in the MP Ordinance, although it mandates the DM’s sanction as a prerequisite for any court to take cognisance of an offence caused by violation of these procedures.

The UP Ordinance also lays down a post-conversion procedure. Post-conversion, within 60 days from the date of conversion, the converted individual is required to submit a declaration (with various personal details) to the DM. The DM will publicly exhibit a copy of the declaration (till the conversion is confirmed) and record any objections to the conversion.  The converted individual must then appear before the DM to establish his/her identity, within 21 days of sending the declaration, and confirm the contents of the declaration.  

Both the Ordinances also prescribe varying punishments for violation of any procedure prescribed by them, as specified in Table 2.

Prohibition on conversions: Both, the UP and MP Ordinances prohibit conversion of religion through means, such as: (i) force, misrepresentation, undue influence, and allurement, or (ii) fraud, or (iii) marriage.  They also prohibit a person from abetting, convincing, and conspiring to such conversions. Further, the Ordinances assign the burden of proof of the lawfulness of religious conversion to: (i) the persons causing or facilitating such conversions, in UP, and (ii) the person accused of causing unlawful conversion, in MP. 

Complaints against unlawful conversions: Both Ordinances allow for police complaints, against unlawful religious conversions, to be registered by: (i) the victim of such conversion, (ii) his/her parents or siblings, or (iii) any other person related to them by blood, and marriage or adoption. The MP Ordinance additionally permits persons related by guardianship or custodianship to also register a complaint, provided they take the leave of the court. Further, the MP Ordinance assigns the power to investigate such complaints to police officers of the rank of Sub-Inspector and above.

Marriages involving religious conversion: As per the UP Ordinance, a marriage is liable to be declared null and void, if: (i) it was done for the sole purpose of unlawful conversion, or vice-versa, and (ii) the religious conversion was not done as per the procedure specified in the Ordinance. Similarly, the MP Ordinance declares a marriage null and void, if: (i) it was done with an intent to convert a person, and (ii) the conversion took place through any of the prohibited means specified under the Ordinance. Further, the MP Ordinance explicitly provides for punishment (as specified in Table 2) for the concealment of religion for the purpose of marriage. 

Right to inheritance and maintenance: The MP Ordinance additionally provides certain safeguards for women and children. It considers children born out of a marriage involving unlawful religious conversion as legitimate and provides for them to have the right to property of only the father (as per the law governing the inheritance of the father). Further, the Ordinance provides for maintenance to be given to: (i) a woman whose marriage is deemed unlawful under the Ordinance, and (ii) her children born out of such a marriage.

Punishment for unlawful conversions: Both the MP and UP Ordinances provide for punishment for causing or facilitating unlawful religious conversion, as specified in Table 1. Also, all offences under both Ordinances are cognisable and non-bailable. 

Additionally, under the UP Ordinance, the accused will be liable to pay compensation of up to five lakh rupees to the victim of conversion and repeat offences will attract double the punishment specified for the respective offence. However, under the MP Ordinance, each repeat offence will attract punishment of a fine, and imprisonment between five and 10 years. Further, it provides for the Session Court to try an accused person, at the same trial, for: (i) an offence under this Ordinance, and (ii) also for other offences he has been charged with, under the Criminal Procedure Code, 1973.

Table 1: Punishments prescribed under the UP and MP Ordinances for offences by individuals for causing/facilitating the conversion

Punishment

Uttar Pradesh

Madhya Pradesh

Mass conversion (conversion of two or more persons at the same time)

Term of imprisonment

3-10 years

5-10 years

Fine Amount 

Rs 50,000 or more

Rs 1,00,000 or more

Conversion of a minor, woman, or person belonging to SC or ST

Term of imprisonment

2-10 years

2-10 years

Fine Amount 

Rs 25,000 or more

Rs 50,000 or more

Any other conversion

Term of imprisonment

1-5 years

1-5 years 

Fine Amount 

Rs 15,000 or more 

Rs 25,000 or more

If any of the above three offences are committed by an organisation, under the UP Ordinance, the registration of the organisation is liable to be cancelled and grants or financial aid from the state government is liable to be discontinued. Under the MP Ordinance, only the registration of such organisations is liable to be cancelled.

* - It is not clear if the Chhattisgarh Law is currently in force or not.

** - Madhya Pradesh originally enacted a law in 1968. And has now replaced it with an Ordinance in 2021.

Note: For Odisha, Jharkhand, and Uttarakhand, some of the penalties have been specified in the Rules published under their respective Acts. For the rest of the states, the penalties have been specified in the respective Acts itself.