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Industry welcomes announcement of new recruitment for DCGI
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Shardul Nautiyal, Mumbai
August 07 , 2024
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In a significant move, the government has announced the imminent recruitment of a new Drug Controller General of India (DCGI), a decision that has been met with widespread relief across the pharmaceutical industry. The tenure of the current DCGI, Dr Rajeev Raghuvanshi, has been marked by considerable controversy and dissatisfaction within the industry.
Industry insiders have long expressed concerns about Raghuvanshi’s approach to drug regulation. Despite having served as DCGI for one and a half years, critics argue that he has failed to grasp the complexities of drug regulation and has shown a clear bias against the Micro, Small, and Medium Enterprises (MSMEs) in the sector. His background in a leading pharmaceutical company, with no prior government or international regulatory experience, has been cited as a major drawback.
Under Raghuvanshi’s leadership, there have been numerous risk-based inspections, leading to the shutdown of many small pharmaceutical companies. These actions, according to industry representatives, are expected to have long-term impacts on drug prices. Notably, despite repeated reports of substandard quality drugs from larger pharmaceutical companies, Raghuvanshi’s inspections have seemingly spared these entities. This has fueled allegations that he is favoring multinational corporations and former associates within the industry.
The discontent extends beyond the MSME sector. A senior state Drug Controller, speaking on the condition of anonymity, described Raghuvanshi as overly authoritative in his dealings with state-level regulators. Additionally, the MSME sector has criticized his methodology for testing cough syrups, which they claim resulted in significant export delays and cancellations.
The pharmaceutical industry feels vindicated by the government’s decision to appoint a new DCGI. They believe this move indicates the government’s acknowledgment of the missteps in Raghuvanshi’s appointment and their willingness to rectify the situation. The industry is optimistic that the new DCGI will be someone from within the Central Drugs Standard Control Organization (CDSCO), with a better understanding of the industry’s needs and challenges.
Industry leaders are hopeful that the new appointment will usher in an era of fair and balanced regulation, where both MSMEs and larger companies are treated equitably. They anticipate that the new DCGI will prioritize guidance and support over punitive actions, fostering a more conducive environment for the growth and development of the pharmaceutical sector in India.
The government’s decision to listen to the industry’s concerns and act upon them is a positive step forward, and stakeholders are eagerly awaiting the appointment of a new, more experienced and balanced DCGI.
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