Manufacturing firms of pharmaceutical need to comply with the necessary regulatory provision
As the manufacturing firms of pharmaceutical need to comply with the necessary regulatory provision while manufacturing but to comply with this the firm’s faces challenges while going accordingly. Those issues were raised during the Good Manufacturing Practices (GMP) workshop for the manufacturing personnel at Phuentsholing.
The issues were, for instance, the firms require separate import authorization for every single product, validity technical authorization and also for tax exemption on import of raw material for productions of APIs and for those plants and machineries used in the pharmaceutical plants.
Dy. Chief Regulatory Officer, Ngawang Dema from Drug Regulatory Authority said that as per Bhutan Medicines Rules and Regulation, 2012, import authorization is required for all the medicinal products to ensure that only qual- ity or registered products are being imported from authenticated source.
She added that some ingredients are listed internationally as precursor chemicals for illicit manufacture of drugs and this requires additional import permit from Bhutan Narcotic Control Authority. Some medicinal products are banned for import due to health hazards.
One time blanket approval may compromise on the surveillance aspects of regulatory functions. However, regulatory provision requiring import authorization for raw materials which do not fall under the restricted category for manufacturing of medicinal products in the country maybe re-visited and discussed as recommended by our client, she added.
With the launching of G2C system, the issuance of import authorization is also doing through online system but the authority faces challenges with technical, she said that they have tried from this year to operationalize the online system through support of G2C, but there are technical problems associated with it because online process was taking longer than the routine manual one. Hence, this system is under process of review and rectification.
However, she added that through emails, applications are entertained and scanned copies of authorizations are dispatched.
For the validity of the technical authorization, free sale certificate and export authorization is very short and expire early, so she said that the validity of techni- cal authorization is for one year in line with the validity of trade licenses. Other documents such as free sale certificate, export authorizations are from three months to six months.
“We have plans to amend the Medicines Rules and Regulation in consultation with our stakeholders keeping in mind of DRA’s vision as dynamic, reliable and client-centric organization,” said Ngawang Dema.
Currently, the firms were imposed taxes for import of raw material. The issue was raised by the manufacturing firms for exemption of taxes but Ngawang Dema said that exemption of taxes is not directly under the purview of DRA’s jurisdiction; however, she added that they have agreed to discuss this issue with the relevant agencies such as Ministry of Finance and Ministry of Economic Affairs in a way of promoting domestic manufacturers for Pharmaceuticals.
Meanwhile, the GMP Workshop was aimed to promote regulatory compliances and also to discuss on the regulatory provisions unreasonably deterring the growth of their business.
The workshop on basic Principles of Good Manufacturing Practices (GMP) was attended by 23 key personnel from various manufacturing firms such as Active Pharmaceuticals Ingredients, Medical gases, Veterinary Vaccines manufacturer (Biological Production Unit, National Centre for Animal Health, MoFA) and Menjong Sorig Pharmaceuticals (Traditional medicines).