IPO 2022 will be modified by the Economic Coordination Committee (ECC) of the Cabinet to permit government agencies to import pharmaceutical (allopathic) raw materials.
The Import Policy Order (IPO) 2022 will be modified by the Economic Coordination Committee (ECC) of the Cabinet to permit government agencies to import pharmaceutical (allopathic) raw materials.
The summary provided by the Minister of Commerce to the ECC meeting on Wednesday, June 21, 2023, chaired by Finance, stated that under the Import Policy Order 2022, only pharmaceutical industries in possession of a current pharmaceutical manufacturing licence are permitted to import pharmaceutical (allopathic) raw materials of pharmaceutical grade in the form of unprocessed ingredients.
“Provided that the oil adjuvant is to be imported by the federal/provincial government or any other designated government institute/ agency, for the purpose of research/production of vaccines, the same shall be allowed to be imported through registered/ authorized distributor of foreign principal/supplier of pharmaceutical raw material, subject to research and production of vaccines for non-commercial purpose,” the ECC added as a proviso.
The Livestock and Dairy Development Department of the Government of Punjab informed the meeting that its Veterinary Research Institute (VRI) and Foot and Mouth Disease Research Centre (FMDRC) are engaged in the research and production of veterinary vaccines to be used for controlling numerous common diseases in livestock and poultry, particularly Foot and Mouth Disease and Hemorrhagic Septicemia.
The department assigned a work order to M/s Alternative Chemicals (Pvt) Limited Lahore in order to purchase 46,288 kg of montanide oil, a crucial component in the creation of vaccines against the aforementioned diseases.
According to the terms of WO. 2022, M/s Alternative Chemicals (Pvt) Limited, Lahore was ineligible to import montanide oil because it was neither an industrial user nor a manufacturer of pharmaceuticals. In order to relax the restrictions, M/s Alternative Chemicals (Pvt) Ltd, Lahore requested permission from the Ministry of Commerce to import montanide oil for later supply to the government of Punjab.
The Punjab government submitted similar cases for the one-time release of montanide oil for the production of veterinary vaccines in 2017, 2019, 2020, and 2021, the ECC was informed.
According to IPO, 2022, the federal government has the authority to relax any prohibition or restriction imposed by 1PO, 2022 for a single release of any product.
However, granting an exemption annually is not preferred; rather, a suitable policy amendment to account for such import cases is needed.
In order to make the necessary changes to IPO, 2022, the stakeholders were consulted. At an Inter-Ministerial Meeting (IMM) with representatives from the Ministries of Commerce, National Health Services, Regulations and Coordination, Federal Board of Revenue (FBR), Drug Regulatory Authority of Pakistan (DRAP), and Livestock and Dairy Development Department, Government of the Punjab, the participants unanimously decided to make changes to IPO.
The DRAP proposed changing the language in the minutes of the aforementioned inter-ministerial meeting to ensure that montanide adjuvant will only be used for research and non-commercial purposes.
It was suggested by the ECC to include the proviso that reads, “provided that if the oil adjuvant is to be imported by the federal/provincial government or any other designated government institute/ agency, for the purpose of research/production of vaccines, the same shall be allowed to be imported through registered/ authorised distributor of foreign principal/ supplier of pharmaceutical raw material, subject to research and production of vaccines for non-commercial purpose.”
The Ministry of National Health Services Regulations and Coordination and the FBR were consulted as required by the Rules of Business, 1973, and the ECC was also made aware of this.