Academics

ART and PCPNDT-COMPLIANCE ISSUES

Dr Manish Y Machave.

MD DNB MNAMS FICOG LLB.

Dip. Endoscopy(Germany).

Adv Dip Gyn Endoscopy( France).

Introduction- 

Assisted Reproductive Technologies with In Vitro Fertilization Clinics are at a boom. The governing regulation functional at present are the ICMR guidelines with the ART Bill and Surrogacy Bill in the pipeline.

The implementation Of  The PCPNDT act 1994 is an issue which remains controversial to the core. 
There was a Gazetted Notification under The PCPNDT act 1994 on 9 Oct 2014 notification which said that all ART centres have to register under PCPNDT ACT AS

  • Genetic counselling center
  • Genetic clinic
  • Genetic laboratory

In accordance with which prenatal diagnostic technique(test/ procedure) is carried out at the center example-

PND PROCEDURE-(selection of sex)USG/embryo/tissue/fluid/man/woman

PND TEST-USG/Other tests on pregnant woman/conceptus

PND TECNIQUES-Both of above.

The notification also said that there was no need for any new form.

F form was to be filled-

  • A-for all diagnostic procedures/tests
  • B-for non invasive procedure/tests
  • C-for invasive procedures/tests 21(v)-any other
  • D- declaration of patient/ doctor
  • FORM G-form of consent(for invasive techniques.

This article is intended to clear the compliance issues pertaining  to various ART procedures in accordance with The PCPNDT act, 1994.

Compliance Table-

Procedure Forms Yes/no Section/rule Records Section/rule
Follicular study NO NA
Oocyte retrival Yes-G Rule10 G/D as per the case Rule 10,9(2)
Embryo Transfer Yes Rule10 D/E/G Rule 10,9(2)(3)
IUI SCAN N0 NA
IVF Yes Rule 10 D/E/G Rule 10,9(2)(3)
Surrogacy Yes Rule4(3),9(4),10 F/G Rule4(3),9(4),10
ICSI Yes Rule 10 E/G Rule 9(3),10
Semen Analysis NO NA
PGS Yes Rule10 D/E/G Rule 9(2),(3),10
PGD Yes Rule 10 D/E/G Rule 9(2),(3),10
Infertile male patients NO NA
Testicular Biopsy NO NA NA
Body fluids Exempted
NIPT Yes Rule 4(3),9(4),10(1A) F Rule 4(3),9(4),10(1A)

 

Conclusion-

In this era of  skewed interpretation of statutes, it is absolutely essential to stick to standard compliance procedures. No disrepute shall be thumped upon  the subject , its knowledge or the healthcare provider for want of correct documentation.