India has allowed the import of human embryos for artificial reproduction, opening up what is expected to be a huge segment of the medical tourism market.
The decision will allow foreign couples to bring in frozen human embryos and rent a surrogate womb in India for the baby to be born. The relaxed rules will also apply to other infertility-related treatment such as IVF.
The decision was announced through separate notifications by the Central Board of Excise and Customs and the Directorate General of Foreign Trade over the last one month.
To ensure quality control, such imports will have to carry a no-objection certificate from the Indian Council of Medical Research (ICMR).
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“It is not only for foreign nationals but also Indian couples settled abroad if they want to bring frozen embryos to India for infertility treatment or surrogacy,” Hrishikesh Pai, president-elect of the Indian Society of Assisted Reproduction and head of the IVF unit at Lilavati Hospital, Mumbai, told The Indian Express.
“This was not permitted earlier but the new guidelines have streamlined the process and cleared grey areas on their import.”
Although ICMR had recognised the import of human embryos frozen in liquid nitrogen containers for artificial reproduction techniques as proper medical procedure to be conducted in India, doctors said customs and DGFT rules did not permit such imports.
India is a rising global healthcare player with the ability to provide inexpensive but top quality medical care and a large percentage of foreign patients come for treatment of problems linked to fertility.
The medical tourism business is expected to grow by 30 per cent cumulatively to about $2 billion (Rs 12,000 crore) by 2015.
But surrogacy has had to deal with conflicting guidelines and had not taken off.
Experts said since the government has built in a case-by-case approval procedure, it would ensure that human embryos are not brought into the country for research purposes or for the exploitation of surrogates.
According to estimates, even now there are between 400 to 500 surrogacy cases in the country every year of which nearly 70 per cent are from Indian patients. “Import of human embryos has been restricted and only with permission from the ICMR,” said R Muralidharan, executive director, PricewaterhouseCoopers.
ICMR officials said the conditions for granting NOC are stringent.
“The draft Assisted Reproductive Techniques Bill, which is still under consideration of the ministry of health, clearly disallows export of embryo gametes etc unless for personal therapeutic purposes. Imports are allowed so long as there is no sale. There is no restriction on implantation of a imported frozen embryo in a surrogate either but the conditions for granting of NOC are stringent,” one official said.
The documents required for an NOC include a certificate of registration of the ART clinic recommending transfer of embryos/gametes and the clinic in India where the infertility treatment will happen along with name and address of its in-charge.
The foreign clinic has to certify that the infertile woman cannot conceive or that such conception may lead to undesirable medical implications. There has to be certification that at least one of the gametes was from the infertile couple.
The Indian ART clinic has to give a certificate saying which foreign clinic has referred the couple and from which country, including name and address of the couple, while its foreign counterpart has to certify that the embryo was generated in their clinic and there was no sex selection. The couple has to furnish identification documents and proof of marriage.