Spurred by the overseas inspections carried out by the CDSCO officials for the first time in China and the based on the inputs from them, the Health Ministry has made a proposal to set up permanent 'country offices' exclusively for the pharmaceutical sector in some key foreign countries.

The proposed 'India country offices' will inspect the manufacturing facilities which supply drugs and active pharma ingredients to India besides addressing the regulatory issues to help both the importers and exporters from India. The Ministry has now proposed one each such office in at least five countries to begin with.

Sources said the Ministry has suggested setting up of offices in China and South Africa to begin with and the other three countries would be decided in consultation with other stakeholders and concerned Departments like Pharmaceuticals and Commerce.

“The Ministry is seeking a total outlay of Rs.175 crore for five locations. Rs.35 crore is expected to be the total expenses in this regard for one office. This will cover rented accommodation of about Rs.3 crore for five years, furniture, manpower of 6-8 officials (around Rs.10 crore for five years), travel costs and miscellaneous expenses,” sources said.

CDSCO officials for the first time had an overseas inspection of facilities in China some time back as China is a key supplier of bulk drugs to India. The officials had suggested permanent mechanism to hold regular checks, thus prompting the ministry to make the new proposal. Indian exporters were facing another problem in African countries which are prominent markets for them. Fake drugs, purportedly produced by Chinese firms with 'Made in India' labels, were creating problems for the Indian exporters. The proposed country offices are expected to deal with such issues.

“Globalization has fundamentally changed the environment for regulating drug products and created unique regulatory challenges for CDSCO for many reasons. More foreign manufacturing facilities are supplying bulk drugs, medical devices, blood products, diagnostics, anti cancer drugs to India. The volume of imported medicinal products is increasing sharply and there is a greater complexity in supply chain. India also has to be cautious about imports coming from countries with less developed regulatory systems. All these reasons warrant for setting up of permanent offices in key locations,” sources said.