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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:
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:
Yesterday, the Governor of Karnataka promulgated the Karnataka Protection of Right to Freedom of Religion Ordinance, 2022. The Ordinance prohibits forced religious conversions. A Bill with the same provisions as the Ordinance was passed by the Karnataka Legislative Assembly in December 2021. The Bill was pending introduction in the Legislative Council.
In the recent past, Haryana (2022), Madhya Pradesh (2021), and Uttar Pradesh (2021) have passed laws regulating religious conversions. In this blog post, we discuss the key provisions of the Karnataka Ordinance and compare it with existing laws in other states (Table 2).
What religious conversions does the Karnataka Ordinance prohibit?
The Ordinance prohibits forced religious conversions through misrepresentation, coercion, allurement, fraud, or the promise of marriage. Any person who converts another person unlawfully will be penalised, and all offences will be cognizable and non-bailable. Penalties for attempting to forcibly convert someone are highlighted in Table 1. If an institution (such as an orphanage, old age home, or NGO) violates the provisions of the Ordinance, the persons in charge of the institution will be punished as per the provisions in Table 1.
Table 1: Penalties for forced conversion
Conversion of |
Imprisonment |
Fine (in Rs) |
Any person through specified means |
3-5 years |
25,000 |
Minor, woman, SC/ST, or a person of unsound mind |
3-10 years |
50,000 |
Two or more persons (Mass conversion) |
3-10 years |
1,00,000 |
Sources: Karnataka Protection of Right to Freedom of Religion Ordinance, 2022; PRS.
Re-converting to one’s immediate previous religion will not be considered a conversion under the Ordinance. Further, any marriage done for the sole purpose of an unlawful conversion will be prohibited, unless the procedure for religious conversion is followed.
How may one convert their religion?
As per the Ordinance, a person intending to convert their religion is required to send a declaration to the District Magistrate (DM), before and after a conversion ceremony takes place. The pre-conversion declaration must be submitted by both parties (the person converting their religion, and the religious converter), at least 30 days in advance. The Ordinance prescribes penalties for both parties for failing to follow procedure.
After receiving the pre-conversion declarations, the DM will notify the proposed religious conversion in public, and invite objections to the proposed conversion for a period of 30 days. Once a public objection is recorded, the DM will order an enquiry to prove the cause, purpose, and genuine intent of the conversion. If the enquiry finds that an offence has been committed, the DM may initiate criminal action against the convertor. A similar procedure is specified for a post-conversion declaration (by the converted person).
Note that among other states, only Uttar Pradesh requires a post-conversion declaration and a pre-conversion declaration.
After the religious conversion has taken place, the converted person must submit a post-conversion declaration to the DM, within 30 days of the conversion. Further, the converted person must also appear before the DM to confirm their identity and the contents of the declaration. If no complaints are received during this time, the DM will notify the conversion, and inform concerned authorities (employer, officials of various government departments, local government bodies, and heads of educational institutions).
Who may file a complaint?
Similar to laws in other states, any person who has been unlawfully converted, or a person associated to them by blood, marriage, or adoption may file a complaint against an unlawful conversion. Laws in Haryana and Madhya Pradesh allow certain people (those related by blood, adoption, custodianship, or marriage) to file complaints, after seeking permission from the Court. Note that the Karnataka Ordinance allows colleagues (or any associated person) to file a complaint against an unlawful conversion.
*In Chirag Singhvi v. State of Rajasthan, the Rajasthan High Court framed guidelines to regulate religious conversions in the state.