Delhi diagnostic players oppose genetic sample outflow ban order

Move was put in place after Delhi saw a fall in sex ratio at birth for 4th straight year, with officials fearing a return of prenatal gender testing

The Delhi government’s directive banning sending of genetic samples outside the city for advanced prenatal tests has hit opposition, with diagnostic players in the capital citing operational difficulties in complying with the order.

 

This comes after the Annual Report on Registration of Births and Deaths in Delhi 2024 indicated that the city’s sex ratio at birth (SRB) had dropped to 920 girls per 1,000 boys in 2024, down from 922 in 2023.

 

Alarmed at the steady decline in SRB, the directive, dated September 22, asks for all tests, wherever clinically indicated, to be carried out only in registered genetic laboratories within Delhi, which are duly approved under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act.

 

The Delhi government has also asked genetic clinics, genetic counselling centres and genetic laboratories to submit a monthly report and ban any attempts of sex selection practices.

 

The ban has been put in place for tests such as the Non-Invasive Prenatal Test (NIPT) and several types of Preimplantation Genetic Testing (PGT). While tests are done to check for fetal abnormalities, which could be chromosomal or genetic disorders, officials believe that illegal prenatal sex determination may be making a comeback.

 

The city’s sex ratio has been falling consistently since 2020, when it reached its highest level of 933 females per 1,000 males. It dipped to 932 in 2021 and 929 in 2022. “The ratio had only crossed the 900-mark for the first time in 2016, making the reversal a worrying sign,” an official stated.

 

As a result, the government directive states that no genetic material (including but not limited to blood, tissue, gametes, embryos or DNA samples) shall be sent outside the territory of Delhi for purposes of conducting NIPT, PGT or any other pre-natal or pre-implantation genetic testing.

 

However, citing operational challenges, diagnostic players have asked for the directive to be either withdrawn or kept in abeyance till discussions take place with industry stakeholders.

 

“While the intent to strengthen oversight is understandable, in practice this restriction can create significant barriers for patients and providers,” industry body Nathealth said in their representation.

 

Business Standard has seen a copy of Nathealth’s representation.

 

Companies added that many healthcare facilities across NCR and nearby states do not have access to advanced genetic testing equipment or trained manpower. “Delhi itself has just two or three genetic labs, while there may only be 8 to 10 genetic labs in India,” a lab owner in Delhi said.

 

The Nathealth representation also states that forcing all tests to be conducted only within Delhi could result in Delhi labs being overburdened, delayed results and disruption of continuity of care in emergency situations.

 

Executives also stated that the move could also increase costs for both the patients and providers due to logistics, transportation and operational redundancies.

 

“Genome sequencing in such cases is a very expensive prospect as both the machine and kits cost a lot,” another lab owner said.

 

The affordability, he said, can only come with an increased number of samples. “For example, I can do 10 tests in one kit, then I will be able to do it at ₹5,000. If these come down to five samples, then the cost has to go to ₹10,000. If it further falls to two, then accordingly, the rate will increase,” he said, adding that such restrictions may lead to the need for more genomic labs, which in turn could reduce the number of samples coming to each lab.