After India warned China against fake ‘Made in India’ drugs being sold in Africa and other less developed nations, New Delhi has taken to inspecting drug manufacturing firms and manufacturers of sub standard diagnostic kits. China is a key supplier of bulk drugs to India.
India’s Central Drug Standard Control Organization (CDSCO) has said that it is in the process of conducting quality checks at Chinese pharmaceutical equipment factories after a flood of complaints pertaining to low quality diagnostic kits was discovered in India. The manufacturing units including Southwest Synthetic Pharma Company, Intec Product, Suzhoudawn Ray’s Pharma and Hisoanchuannan Pharma Company will be inspected by the Indian officials.
Inspectors from the Health Ministry are expected to inspect about six diagnostic manufacturing units in China regarding which they have already written to the Chinese Food and Drug Authority. On gaining approval for the inspections, a health Ministry official said The inspection will help us know whether the manufacturing units are adhering to the Good Manufacturing Practices (GMP) or not, so that further action can be taken.”
Following the inspection, the Health Ministry has also made a proposal to set up permanent ‘country offices’ exclusively for the pharmaceutical sector in some key foreign countries, including China and South Africa. 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. “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.
In May last year, India’s health Ministry sent a delegation to China, after several import licenses were cancelled failing to comply with Good Manufacturing Practices (GMP). However no major irregularities found in the drug manufacturing units.