To ensure the availability of raw materials post lockdown in the country, domestic drug manufacturers have appealed to Drugs Controller General of India (DCGI) to extend validity of Form 10 (import licence) and Form 41 (registration certificate) by three months.
A number of import licences and registration certificates would be expired by April 14 when the 21-day lockdown announced by the government to contain the spread of coronavirus would end. After lockdown, the applicants will submit application for renewal of the licences. Licences get renewed within three months from the date of receipt of application by the licensing authority. By the time there will be several raw materials out of the stock thus significantly hampering the production of drugs in the country.
Amit Chawla, general secretary of Madhya Pradesh Small Scale Drug Manufacturers’ Association told that, “The three-month extension of validity of Form 10 and Form 41 will help manufacturers import raw materials and simultaneously submit application for renewal of the licences post lockdown.With this, the applicants will have space to get their licences renewed without hampering product import so that there is no short supply of raw materials.”
On the other hand, this will also ease out resources and efforts to handle the backlog which will get created later across the pharma industry, he further added.
The registration certificate is issued for drugs intended to be imported into India under Form 41 and import license is issued under Form 10. An applicant can apply for both registration certificate (Form 41) and import license (Form 10) together.
India, which is pharmacy to the world, imports as much as 70 per cent of raw materials —active pharmaceutical ingredients (APIs), key starting materials and intermediates from China.