AHMEDABAD: The US is an important market for Indian pharmaceutical companies as India exports more than $4 billion or nearly Rs 25,000 crore of drug pro ducts to the US annually . Gujarat amounts for 28% of the India’s drug exports, as the four major Gujarat-based pharma companies alone exported products worth Rs 2,278 crore in the second quarter.
This is why the US Food and Drug Administration (FDA) has an office in India and the country has the most USFDA-approved plants for any country outside the US.
To improve the local bodies’ inspection norms in the pharmaceutical sector, the USFDA conducted its first workshop in India for central and state drug regulators in collaboration with Central Drugs Stan dard Control Organization (CDSCO) of India at Gujarat Forensic Sciences Uni versity (GFSU) on Monday and Tuesday .
Leslie K Ball, assistant commissioner for international programmes, USFDA and Dr G N Singh, drugs controller general of India, provided objectives and expectations from both sides. Over 100 officials from northern, western and central states participated. “Some 55% of drug produced in India are exported and the US is an important stakeholder. The event is primarily a capacity-building exercise to improve drug quality control at all stages of manufacturing. This is the first such workshop under an MoU signed by the two govern ments. The second such event will be held in Banga lore later this month for so uthern states,” said an organizer.
Gujarat officials said hat the state today has over 3,100 pharmaceutical plants, ranging from mega corporates to small-scale industries, many of which supply drugs to the US or prepare pharmaceutical products on to order.A number of such units undergo USFDA inspections.
Officials said that many times, drug batches are rejected in the US as they don’t meet the required standards. Such efforts, where inspectors learn of about good manufacturing practices (GMP), will boost exports not only to the US but also to other countries, they added.
Some topics covered included the USFDA inspection programme, pre-approval inspection, product validation and assuring quality , manual and automated systems and data integrity .
