The Haryana Pharmaceutical Manufacturers Association (HPMA) has moved Punjab and Haryana High Court challenging the Drug Controller General of India's (DCGI) order dated 15.01.2013 in which the DCGI had asked the manufacturers to submit safety and efficacy data of FDC drugs approved by the state drug controllers before October 1, 2012 without the DCGI nod.

In its writ petition, the Association prayed the court for quashing the DCGI orders dated 15.01.2013 and 05.07.2013 terming them as illegal, without legislative competence, arbitrary and discriminatory, unconstitutional and against the principle of natural justice and also against the provisions of the Drugs and Cosmetics Act, 1940 and also the Drugs and Cosmetics Rules, 1945.

The Association in its petition also asked the court to direct the DCGI and the Haryana state drug controller not to take any coercive action against the petitioner or any manufacturer of the state seeking compliance of the impugned letters during the pendency of the writ petition in the interest of justice.

“The action of the respondent No. 2 (DCGI) is also violative of Article 19 of the Constitution of India in as much as the same amounts to unreasonable restriction on the Fundamental Right to Trade as envisaged therein. As submitted hereinabove, the approvals in respect of the FDCs available in the market have been granted by the State Licensing Authorities at the relevant point of time and, therefore, it would not be fair and reasonable for the respondent No. 2 to find fault with such approvals by the State Licensing Authorities subsequently, particularly in the light of the fact that the Rules were absolutely silent about this aspect of the matter prior to 01.05.2002,” the petition said.

The Association in its writ petition further argued, “Furthermore, the concomitant use of these FDCs from the last many years without any adverse drug reaction would also make it imperative for the Government to reconsider this issue from the perspective of the entire pharmaceutical industry for the reason that they have been made to Act upon the approvals, so granted by the State Licensing Authority. In this view of the matter, the letter/directives issued by the respondent No. 2, which are impugned in the present writ petition, would amount to unreasonable restriction on Right to Trade, as envisaged under Article 19 of the Constitution of India.”

The Punjab Drug Manufacturers Association has also joined as a party in the case.

Meanwhile, according to the DCGI’s latest order, the last date for submitting the efficacy data of SLA-approved FDCs to the DCGI office has ended on September 30, 2013.