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Indian pharmas call on FDA to perform 'virtual' facility checks during COVID-19 inspection lockdown

India, one of the largest drug exporters in the world, has been hit hard by the novel coronavirus pandemic as global lockdowns have complicated daily operations. On one measure—the FDA's nearly two-month ban on foreign inspections—Indian drugmakers are pushing back. And they may have come up with a novel solution.

Major Indian pharmaceutical companies are asking the FDA to conduct "desk reviews" or virtual facility inspections during the pandemic in order to "ensure the continuous supply of much-needed drugs in the United States," according to a letter from the Indian Pharmaceutical Alliance (IPA) obtained by FiercePharma.

In correspondence dated April 20 to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, the alliance asked for virtual reviews of facilities that are new, are slated to produce a new class of drugs or have completed a corrective action plan following a previous inspection failure.

Among the alliance's members are India's largest drug manufacturers, including Cipla, Cadila, Dr. Reddy's Laboratories and Abbott India.

The group also requested the FDA consider recognizing inspections by foreign regulators and temporarily waiving on-site inspections "based on past inspection history and the critical nature of products, such as drug shortages or products that do not currently have generic alternatives."

If the agency agreed to the temporary measures, "companies would individually reach out to the FDA with regards to inspections or re-inspections pending so that the agency can propose the best path to move forward under the current circumstances for each company," the letter read.

The FDA on Wednesday confirmed it had received the alliance's letter and so far has not performed any livestream video inspections.

"These alternative approaches to on-site inspection have provided FDA with useful information," a spokesman said.

The FDA pointed to a March 10 order to outline its current policy, which stipulates that the inspection ban would continue through April. The agency hasn't publicly announced whether the ban will be renewed.

If the FDA does choose to renew its order, it could continue to hamstring India's production of generic and branded meds on which the U.S. relies. The move would also potentially damage India's attempt to flex its muscle as a global pharmaceuticals producer at the expense of world leader China.

Earlier this month, Bloomberg reported the Indian government is planning to escalate domestic production of pharmaceutical ingredients to counteract a perceived over-reliance on Chinese imports now hampered by COVID-19 shutdowns.

India has identified and prioritized production of 53 raw materials and active pharmaceutical ingredients (APIs) as part of its "China-plus-one" policy to fill in supply gaps of affordable medicines, sources told the outlet. The plan includes investing $1.3 billion in domestic pharmaceutical producers and potentially reviving state-run companies to ramp up cheap generic production.

According to Bloomberg, 70% of India's imports of APIs come from China, totaling $2.4 billion of India's $3.56 billion in import spending for those products each year. In early march, India stopped exports of 26 APIs and drugs that range from paracetamol––the ingredient in Tylenol––to antivirals like acyclovir for treating shingles and antibiotic neomycin. India is reportedly upping production of paracetamol and antibiotics penicillin and ciprofloxacin.

Apr 30, 2020 


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