Absence of drug controller hurting MP medicine firms

MP's small and medium drug manufacturers, which are mainly located in Indore and Pithampur, are crying themselves hoarse due to the huge business losses being incurred due to non clearance and non-approvals from the drug controller's department.

The post of the drug controller has been lying vacant for the last few months. As a result, applications of good manufacturing practice certificate, new drug licences, renewal of licences, certification of market standing and other such certificates, necessary for pharmaceutical industry, are piling up.

"A drug manufacturer cannot participate in new tenders, exports or new business until the state drug controller grants licences or certificates. The state drug units are mainly small and medium industries and are losing businesses to other states," Darshan Kataria, general secretary of Pithampur Audyogik Sangathan, told Business Standard.

Pithampur houses more than 100 units that participates in various tenders invited by states. As many as 10 new units, which have plants for investment in Pithampur Special economic zone, are reportedly waiting for clearances from drug department.

State Chief Secretary Rakesh Sahni said: "We have appointed a full-time controller today and he will look after the drug related queries." Madhya Pradesh is the only state in India where a good manufacturing certificate is issued for one year against the normal global practice of five years.

"It is very difficult for a drug manufacturer to compete in foreign countries with only a year's GMP," an industry source said. State Health Minister Ajay Vishnoi, Principal Secretary Ashwin Dani and Secretary O Mundra were not available for comment.

According to industry sources, the drugs units in MP have a combined worth of Rs 1,000 crore their exports are worth an equal amount. This year as many as 25 companies migrated from Madhya Pradesh due to slow process in regulator's department.