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...
Full text at GMPnews.Net