India’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), may consider a proposal to review the correct disposal of machinery from non-compliant or closed pharmaceutical units to stop potential diversion for manufacturing spurious or contraband drugs.
This comes after the Rajasthan drug-control department raised the issue at the meeting of the Drugs Consultative Committee (DCC), an advisory panel of the CDSCO, on September 18.
According to the minutes of the meeting reviewed by Business Standard, the DCC deliberated on the proposal and opined that even if some regulatory framework is created, its implementation seems to be very poor.
“The committee observed that an effective mechanism would have to cover the wider supply chain of pharmaceutical machinery and not merely disposal of machinery by a closed unit,” the minutes stated.
Consequently, the DCC asked the drug controller, Rajasthan, to submit a detailed proposal covering identification, manufacture or supply, ownership, transfer, decommissioning, and disposal of pharmaceutical machinery.
The proposal will also have to include new monitoring mechanisms, resource implications, and other aspects like scrap monitoring after disposal. It may thereafter be placed before the DCC for further deliberation.
The step comes at the same time when recommendations from the National Human Rights Commission (NHRC) to curb spurious and counterfeit medicines have been sent to the DCC. These recommendations include implementation of a centralised registration system for medicines sold in India, along with a portal to track real time their movement through supply chains, and dynamic QR codes for authentication.
The steps also come after Rajasthan saw several cases of distribution of spurious drugs in the last few months. At least seven women died in Kota and Bikaner districts of the state due to complications caused by postpartum administration of spurious oxytocin injections.
The state drug-control department cancelled the licence of a Kota-based pharma distributor over alleged sale of several batches of spurious oxytocin injections and other irregularities.
In a separate case, the state drug-control department also seized spurious and expired drugs worth ₹4 crore from a pharma warehouse in Bhiwadi last month.
