Withdrawal of exemption in COVID-19 vaccine import: SHC suspends DRAP’s notification

KARACHI: The Sindh High Court on Thursday suspended the drug regulatory authority’s notification with regard to the withdrawal of exemption in Covid-19 vaccines import to a private pharma company, importing one million life saving doses of Sputnik-V.

The interim order came on a lawsuit filed by the pharma company engaged in dealing with the import of one million Covid-19 vaccine Gam-Covid-Vac/Sputnik V in Pakistan against withdrawal of drug pricing exemption in Covid-19.

The plaintiff counsel submitted in the lawsuit that the DRAP has rescinded its earlier notification issued on February 2, 2021 under which it exempted the import of Covid-19 vaccine for sale in hospitals and institutions from operation of drug pricing mechanism under the DRAP law for a period of six months or till the market prices of those vaccines become available in order to proceed further as per the Drug Pricing Policy-2018, whichever is earlier subject to the conditions.

According to the conditions, the vaccines shall be registered or approved for emergency use authorisation by the registration board of the DRAP and the vaccine shall not be sold or distributed in the market. The plaintiff counsel submitted that his client had applied for registration for import and sale of the Covid-19 vaccine, which was granted by the Government of Pakistan on February 1, 2021.

He said that it was specifically stated in the aforesaid letter that the price of the vaccine will be communicated as and when fixed by the federal government.

He said that in view of the exemption granted by the federal government, the plaintiff entered into a vaccine supply agreement on March 10, 2021 with foreign seller/exporter for the import of one million doses of Covid-19 and out of one million does of the vaccine, 50,000 doses have already arrived in Karachi and have been cleared by the Customs authorities.

The counsel submitted that due to the issuance of the impugned notification, the exemption granted to the Covid-19 vaccine issued on February 2 has been rescinded by the federal government and as a result of such arbitrary, malafide and illegal action on their part, the federal government is now creating hurdles in the sale and administration of the vaccine and has expressed its intention to claim duties, taxes, cesses, etc, thereon threatening that the vaccines will not be released and or allowed to be administered without such payments.

He submitted that the action of the federal government was illegal in view of the settled law that a past and closed transaction cannot be disturbed through an executive action. The counsel contended that the defendants ought to have facilitated the plaintiff in arranging the subject vaccine during the current crises rather than creating obstacles in this matter of national interest.

The SHC’s single bench of Justice Nadeem Akhtar, after preliminary hearing of the lawsuit, issued notices to the Ministry of Health Sciences, DRAP, director (costing and pricing) and others and directed them to file their affidavits and rejoinders on the next date of hearing.

The court has suspended the operation of impugned notification of DRAP issued on March 18 to the extent of Covid-19 vaccine Sputnik-V imported and sold by the plaintiff pharma company.