Indoco Remedies gets some respite from UKMHRA, allowed to supply critical products
The UKMHRA’s statement gives temporary respite, however, the compliance issues need to be addressed urgently.
Indoco Remedies has informed that UK-MHRA has issued a statement of non-compliance and restricted GMP certificate to permit continued manufacture and testing of product considered to be medically critical or to ensure continuity of supply.
In March 2018, UK drug regulatory, UK-MHRA issued 3 critical and 4 major observations at its Goa drug manufacturing facility (Goa – Plant I).
The company has said that UKMHRA statement indicates that, there is no evidence of product having been impacted and therefore the inspectorate does not recommend that the products are recalled.
Indoco is in communication with the European Health authorities is hopeful of an early resolution. Indoco will be able to supply some critically important products from this facility as per the press release. The list of such product is being finalized by MHRA and other national authorities.
The company has said that this will temporarily impact its European business and will try to minimize the impact by transferring the site from the affected Goa I facility to other manufacturing facilities at Goa III and Baddi I, which have a valid EU GMP certification.
Exports from Goa solid dosage plant constitute less than 10% of the Indoco’s total exports and less than 4% of the total sales. This is also the same plant on which USFDA has issued eight observations in February 2018. The USFDA has also issued a warning letter on Indoco’s other two Goa plants in 2017 and a closeout letter is yet to be issued.
While this gives a temporary respite to the company, the compliance issues need to be urgently addressed in order to keep the three Goa units fully operations.
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