According to FPME, the new rule has adversely impacted pharma exports, causing a loss estimated at $500 million. “This is severely impacting the growth and global competitiveness of India’s pharmaceutical exports,” said the spokesperson. The new rule has a significant humanitarian concern as patients visiting India for medical tourism and Indians residing abroad are unable to access the essential medicines, added the spokesperson.
India has been a major producer and exporter of affordable, high quality medicines for oncology, enzyme deficiencies, autoimmune diseases and many other critical medicines to various developed and developing countries.
“Even people of Indian origin sitting in other countries cannot procure drugs from India. There was no such restriction earlier. The suppliers were sending drugs as the law permits it. There is mostly no restriction on export under various laws of our country that govern the prohibition of exports from India like the Customs Act, the foreign trade Act, among others. Long exported products now face restriction causing back log, market share loss and potential shortages,” said another person on condition of anonymity.
The FPME, which met senior officials in the drug regulator’s office last week, had asked for putting this circular in abeyance as they believe that the gap is filled by counterfeit products. “No such labeling restrictions similar to this are being followed by any other country,” added the person. However, government officials said that the same has been done to check misuse.
The label “For sale in India only” is being used as per patents law which means the patent holder who has a patent in India for a product is given exclusive rights and protection over their product which is effective only within the territory of India.
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