Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
1. An Indian pharmaceutical manufacturer has delayed commercial supplies of a recently launched diabetes therapy after identifying quality issues in certain production batches. The manufacturer is investigating the cause and implementing corrective measures, while confirming no impact on patient safety or existing regulatory filings.
Source: short-url.cc/1yS8o
2. India’s Rajasthan government has reportedly ordered the recall of Dinoprostone Gel, a labour-inducing medicine, after it failed quality testing. The state drug control department has directed the withdrawal of the affected batch and initiated regulatory action against the manufacturer. The recall reflects Rajasthan’s strengthened drug quality surveillance framework and is expected to increase regulatory scrutiny of pharmaceutical manufacturers supplying medicines under government procurement programmes.
Source: short-url.cc/1tkZK
3. India’s Ministry of Health and Family Welfare (MoHFW) has notified the amendment to the Drugs Rules, 1945, to designate Navi Mumbai as an additional port for the import of drugs under the prescribed regulatory framework. The amendment expands the list of notified ports for drug imports. The notification is expected to facilitate import operations, strengthen regulatory administration and improve logistical efficiency for pharmaceutical importers and other stakeholders engaged in the supply chain.
Source: short-url.cc/1tkZV
4. India’s Central Drugs Standard Control Organisation (CDSCO) has reportedly directed manufacturers to update the safety labels and prescribing information for several common antimicrobial drugs due to newly identified adverse reactions. The revised labels are intended to improve the safe use of these medicines by strengthening risk communication for healthcare professionals and patients, while reinforcing India’s pharmacovigilance and drug safety monitoring framework.
Source: short-url.cc/1tk-1
5. India’s drug regulator, CDSCO, has reportedly proposed to bring mandatory registration for manufacturers and suppliers of pharmaceutical packaging materials and be governed under the Drugs Rules, 1945. A sub-committee will be set up to examine the necessity and feasibility for registered printing entities. Pharmaceutical packaging manufacturers are currently only indirectly regulated via drug manufacturers’ Schedule M vendor qualification systems, which regulators now deem inadequate to prevent misuse of genuine packaging.
Source: short-url.cc/1tk-6