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Blacklist manufacturers of substandard drugs who made it a habit, Says DCC
In a significant recent development aimed at improving drug regulatory measures, the Drugs Consultative Committee (DCC), an advisory body established by the Central Government, has proposed the creation of a list of manufacturers who consistently produce Not of Standard Quality (NSQ) drugs, with plans to blacklist them.
According to media reports, during its 63rd hybrid meeting at the end of January, chaired by Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), the committee expressed worry about specific manufacturers' recurring production of NSQ pharmaceuticals. Dr Raghuvanshi underlined the importance of rigorously monitoring such repeat offenders in the future.
"It was discussed that blacklisting such manufacturers and preparing a list of such offenders so that the government procurement agencies become careful before procuring drugs from such manufacturers," remarked Dr Raghuvanshi.
During the discussion, it was revealed that several states don't regularly share their NSQ data with central authorities. The committee emphasized the importance of timely and frequent data exchange for website publication and urged all governments to actively participate in this process.
In addition, the Drugs Controller General of India (DCGI) has advised state licencing authorities (SLAs) to expand their state drug testing laboratories with central government funds. This programme is intended to ease the burden on central drug labs, which are now flooded with samples sent in by CDSCO drug inspectors.
The DCGI also asked for immediate action to integrate SLAs into the Online National Drugs Licencing System (ONDLS) to speed application processes starting April 1, 2024, stating that physical applications will no longer be accepted for submissions made through the system.
During a recent meeting, the DCGI emphasized the need for state authorities to take immediate action against the proliferation of similar or identical brands of different drug formulations across different therapeutic categories by various manufacturers in the domestic market.
During the meeting, the committee reviewed a proposal that had been previously discussed. The proposal aimed to standardize enforcement through risk-based inspections of drug manufacturing sites. The guidance document was collaboratively created with CDSCO and State and Union Territory Licensing Authorities. The committee approved the guidance document without any objections from SLAs.
In addition, the DCGI emphasised the imperative of enhancing infrastructure for regulating medical devices across states, including manpower and laboratory facilities, recognising it as an emerging area of concern.
The 63rd DCC meeting, convened to deliberate on crucial agendas for ensuring uniform implementation of the Drugs and Cosmetics Act and Rules, underlined the commitment of regulatory authorities to safeguard public health and maintain the integrity of the pharmaceutical industry.
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