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The pharmaceutical exporters in the country have urged the government to reduce the timeline for getting manufacturing license for pharmaceutical manufacturers for exports, so that pharmaceutical exports are not affected.
For obtaining license even for the products being transferred from one site to other site and also for grant of license for existing age old products under different brand names for export purposes, the manufacturers have to take test license generating BE and stability data and it takes about 6-9 months for getting the license, Bhavin Mehta, Committee Of Administration (CoA) member, Pharmexcil, said.
The manufacturing license is the license issued by the State Licensing Authority which should be enclosed along with each application for the required location to manufacture the drug for export purpose.
As all the exporters are following importing country's norms like dossier filing and stability studies submissions and hence for exports licenses should be granted without linking with stability studies in order to shorten the period of dossier filling.
A representation to Drug Controller General of India (DCGI) has been made by Pharmexcil to reconsider their circular as it is affecting the exports which is growing at double digit after many years.
Ministry of health and family welfare had issued a circular on April 3, 2017 mandating the applicant to submit the result of bioequivalence study referred to schedule Y along with application for grant of license of oral dosage form of drugs specified in category II and category IV of the biopharmaceutical classification system.
Again on April, 2018, ministry of health and family welfare came out with another circular mandating the applicants to submit the evidences of stability, safety of excipients, etc to State Licensing Authority along with the application before grant of product manufacturing licenses.
DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
The Pharmaceutical Export Promotion Council of India (Pharmexcil)'s year-end report has pegged the total pharma exports from India at US$ 19.14 billion for 2018-19 with a growth of 10.72 per cent over US$ 17.28 billion in pharma exports last year.
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