The Drug Controller General of India has decided to move courts on the multiple stay orders that have put a brake in its efforts towards centralising issuance of the WHO pharma export certificate. ?The DCGI office could file a counter-affidavit in the Madras High Court as soon as Wednesday evening while it would appeal to vacate the stay before the Karnataka High Court on Friday in most likelihood,? a DCGI official told FE.
The Madras High Court had stayed the DCGI?s order three times while the Bangalore High Court stayed it once within a span of ten days on the plea of drug inspectors and manufacturers. The latest stay order was granted on October 23, on Confederation of Indian Pharmaceutical Industries? plea, which has stayed the DCGI move for eight weeks. The DCGI would appeal for an early vacation of the order. The industry experts told FE that DCGI?s appeal rests on strong ground. ?Firstly, the exporters had challenged the DCGI?s power to implement such a move, which according to them is not the national regulatory authority under the Drug and Cosmetics Act (DCA). But the DCA doesn?t directly regulate exports, it regulates only manufacturing, sale and imports and DCGI is the closest approximation to a national regulatory authority that we have in the country by any stretch of imagination,? said a legal counsel. He pointed out that in its rules WHO refers to a competent authority, it doesn?t say ?authority(ies)?, which indirectly warns against creating multiplicity of agencies to issue the certificate.
DCGI officials say that the court would take cognizance of the fact that the action of DCGI to centralise the issuance of CoPP was triggered by WHO?s repeated requests and the certificate issued is a WHO stamp at the end of the day.
