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Granules India said that it is voluntarily recalling ranitidine tablets used to treat ulcers of the stomach and intestines. "Ranitidine is being recalled by various producers from the US market, as they contain unacceptable levels of N — nitrosodimethylamine (NDMA). The voluntary ongoing recall is a class II recall," the company said in a BSE filing. "The company is in the process of recall from channel partners and the exact quantities are being estimated, " it added. The company believes that this will not have any material impact on its financials.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week released a new guideline explaining its pre-accession procedure for competent authorities wishing to join the inspection scheme. Membership in PIC/S is open to any competent authority “having the arrangements necessary to apply an inspection system comparable to that enforced by” existing members. “The scheme is primarily based on mutual confidence between participating authorities (PA). Such confidence can only be achieved on the basis of a thorough knowledge of each other’s inspection systems and inspection practice and standards,” PIC/S writes. In light of varying good manufacturing practice (GMP) regulations and quality systems (QS) applied by regulators, PIC/S has opted to split its initiation process into two phases: pre-accession and accession. PIC/S says the purpose of the pre-accession procedure is to allow interested regulators “to better understand what PIC/S is and what the expectations are for becoming...