Herbal or Unani medicines covered under DRAP Act, rules SHC

Any product that is intended for a health-related purpose and contains a substance that comes within the list of the substances set out in the definition of food supplements, etc is a drug within the purview of the Drug Regulatory Authority of Pakistan Act regardless of whether it is intended for human or animal use, the Sindh High Court declared on Monday.

Issuing a detailed judgment on petitions of pharmaceutical companies with regard to the applicability of the DRAP Act to various products manufactured, sold, used or imported by them, including Unani medicines, prescriptions and preparations, food supplements, animal feeds, etc, an SHC’s division bench headed by Justice Munib Akhtar observed that definitions in the DRAP 2014 Rules cover both what the petitioners refer to as food or health supplements as well as animal feed.

The court observed that definitions as used in the 2014 Rules cannot therefore be regarded as beyond or outside the scope of the DRAP Act. The court also directed the Drug Regulatory Authority of Pakistan to issue proper guidelines on what is meant by pharmaceutical dosage forms in relation to food, dietary and health supplements, dealing separately with humans and animals.

It directed that dosage forms and routes of administration and any other matters considered relevant or applicable by DRAP shall be properly set out in those guidelines, which should be immediately and prominently posted on the home page of the authority’s website.

The court observed that simultaneously with posting the guidelines on its website, the authority shall issue a notice to each petitioning company and give a hearing as to whether the said 33 product/substance comes within the scope of the 2014 Rules or the DRAP Act. The Authority shall then, by way of a reasoned order, issue a determination as to whether the 2014 Rules or the DRAP Act are applicable or not.

Preferably, such determination shall be issued within 10 days of the conclusion of the hearing, the court stated, adding that any person aggrieved by any such determination shall be entitled to seek relief before the relevant forum where proceedings are appropriate.

The court observed that interim orders made in any petition shall continue but will lapse 30 days from the date on which the guidelines are posted as above or the date on which the determination is made, whichever is later. However, if a petitioner fails or refuses to appear before the authority or attempts to delay or frustrate the proceedings or the conclusion thereof, the authority may, at any time after the expiry of the 30 days, declare by an order in writing setting out its reasons for doing so, in which case the interim orders shall lapse immediately on the making of such an order.

The counsel representing the petitioning companies that deal with Unani medicines and preparations submitted that his clients’ products did not come within the meaning of “drug” as contained in the 1976 Act. He submitted that Parliament while acting under Article 144 could only enact a law establishing a drug regulatory authority but could not alter the meaning of “drug”, whereas this was exactly what the DRAP Act purported to do.

Additional advocate general argued that traditional medicines, which included medicines prepared under the Unani system, had always been within the meaning of the drugs as contained in the 1976 Act. He added that proper reading of Section 3(g)(i) of the 1976 Act fully established that Unani medicines, etc were well within the meaning of “drug” as therein contained besides insofar as food supplements and the other products involved in the various petitions were concerned and that with the passage of time it was recognised that they also had to be regarded as drugs.

The provincial law officer contended that the definitions of traditional/alternative medicines and food supplements as contained in the DRAP Act only reflected the changes in approach and thinking that had come about between 1976 and 2012. He submitted there was no discrimination or violation of any right that inhered in these petitioners nor had any damage been caused to any of their interests. He further said that food supplements also come within the scope of Section 3(g)(i) of the 1976 Act.