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:
The Surrogacy (Regulation) Bill, 2016 was introduced in Lok Sabha on November 21, 2016 and is listed for passage this week. The Bill regulates altruistic surrogacy and prohibits commercial surrogacy. We present a brief overview of the Bill and some issues that may need to be considered:
How is surrogacy regulated under the Bill?
The Bill defines surrogacy as a practice where a woman gives birth to a child for an eligible couple and agrees to hand over the child after the birth to them. The Bill allows altruistic surrogacy which involves a surrogacy arrangement where the monetary reward only involves medical expenses and insurance coverage for the surrogate mother. Commercial surrogacy is prohibited under the Bill. This type of surrogacy includes a monetary benefit or reward (in cash or kind) that exceeds basic medical expenses and insurance for the surrogate mother.
What is the eligibility criteria for couples intending to commission surrogacy?
In order to be eligible, the couple intending to commission a surrogacy arrangement must be a close relative of the surrogate mother. In addition, the couple has to prove that they fulfil all of the following conditions:
Additional eligibility conditions that the intending couple need to meet may be specified by regulations. It could be argued that the qualifying conditions for surrogacy should be specified in the Bill and not be delegated to regulations.
Who is a close relative under the Bill?
The Bill does not define the term close relative.
Who is eligible to be a surrogate mother?
The surrogate mother, apart from proving that she is a close relative of the couple intending the surrogacy, also has to prove all the following conditions:
What will be the legal status of a surrogate child?
The Bill states that any child born out of a surrogacy procedure shall be the biological child of the intending couple and will be entitled to all rights and privileges that are available to a natural child.
What is the process for commissioning a surrogacy?
The intending couple and the surrogate mother can undergo a surrogacy procedure only at surrogacy clinics that are registered with the government. To initiate the procedure, the couple and the surrogate mother need to possess certificates to prove that there are eligible. These certificates will be granted by a government authority if the couple and the surrogate mother fulfill all the conditions mentioned above. The Bill does not specify a time period within which the authority needs to grant the certificates. Further, the Bill does not specify a review or appeal procedure in case the application for the certificates is rejected.
What is the penalty for engaging in commercial surrogacy under the Bill?
The Bill specifies that any person who takes the aid of a doctor or a surrogacy clinic in order to conduct commercial surrogacy will be punishable with imprisonment for a minimum term of five years and a fine that may extend to five lakh rupees.
Offences such as (i) undertaking or advertising commercial surrogacy; (ii) exploiting or abandoning the surrogate mother or child; and (iii) selling or importing human embryo or gametes for surrogacy will attract a minimum penalty of 10 years and a fine up to 10 lakh rupees.
[This post has been co – authored by Nivedita Rao]
