In yet another major setback to the Union health ministry's efforts to make a backdoor entry to the post of Drug Controller General of India (DCGI), the Supreme Court has ordered that Madras High Court's earlier stay on the Recruitment Rule (RR) framed by the ministry in June last year for the appointment of DCGI should be continued.

Hearing a writ petition filed by Dilip Kumar, secretary, Tamil Nadu branch, Indian Pharmacy Graduates Association (IPGA), the Supreme Court barred the government from appointing anybody as DCGI as per the new RR till the  pendency of the case in Madras High Court.

The supreme court's new order today practically nullified the order of the another bench in Madras High Court under which it had vacated the stay order of the earlier bench.  After the stay was vacated by the bench, the health ministry was going ahead with the process for the appointment of new DCGI and according to sources, it is in an advanced stage.

Earlier, the IPGA secretary had challenged the health ministry's RR on the plea that the ministry has tailor-made the new rules to fit its nominee in the post of DCGI. As per the D&C Act, the required qualification for the post of DCGI is a degree in pharmacy, pharmaceutical chemistry or degree in medicine with specialization in clinical pharmacology or microbiology from a University established in India by law.

But the qualifications framed in the new RR is not in consonance with Rule 49(A) and 50(A) of the D&C Act. The qualification clause in the D&C Rules does not demand a post graduate in Chemistry for DCGI post. But, the RR seeks applications from those who are possessing post graduate degree in chemistry, biochemistry and pharmaceutical chemistry in addition to the prescribed qualifications in the Act. The experience prescribed in advertisement is also in violation of the experience norms stipulated in the drugs and cosmetics rules, Kumar said.

As per the new RR, the applicant should possess a “graduate degree in pharmacy or pharmaceutical chemistry or in medicine with specialization in clinical pharmacology or microbiology from a recognized university established in India by law; postgraduate degree in pharmacy/pharmaceutical chemistry/biochemistry/chemistry/microbiology/pharmacology from a recognized university or equivalent; and 15 years experience in manufacture or testing of drugs in a concern of repute or enforcement of the provisions of the Drugs and Cosmetics Act, 1940 and Rules.”

The health ministry came out with a new RR in June last year after a public interest litigation was filed in the Madras High Court by a former regulatory officer of the Tamil Nadu State Drug Control Administration seeking an inquiry into the appointment of the Dr Surinder Singh as DCGI.