Significant regulatory scrutiny and reform are currently being implemented in India’s pharmaceutical industry, which is well-known worldwide for its size and production capacity. This is evident from recent steps made by the Drugs Controller General of India (DCGI). By June 2024, the Central Drugs Standard Control Organization (CDSCO) in India had ordered more than 36% of the drug manufacturing facilities it had inspected to stop operating because they had not complied with regulations. This development highlights important industry concerns about documentation, quality control, and good manufacturing practices (GMP) compliance.
The regulatory crackdown started in December 2022 when CDSCO launched risk-based inspections with the goal of determining the degree of compliance among Indian pharmaceutical production plants. About 36% of the 400 units that were inspected at this time were forced to temporarily shut down, according to DCGI Rajeev Raghuvanshi. Of these, roughly 10% made the decision to leave the sector permanently after realizing they could no longer produce the necessary level of quality. Following the implementation of corrective and preventive action plans to address identified issues, the remaining units were granted permission to resume operations.
Within the larger endeavor to improve the general quality and safety of pharmaceutical products made in India—a country with around 10,000 pharmaceutical units, the majority of which are small and medium-sized businesses (SMEs)—are the measures undertaken by CDSCO. Even though these units contribute significantly to the industry’s output, many of them have been found to be deficient in important areas like proper documentation procedures, validation procedures, and well-stocked quality control laboratories. These flaws put consumer safety and product quality at risk, calling for strict regulatory supervision and action.
After earlier occurrences that sparked worries about the quality of Indian pharmaceutical exports abroad, the regulatory environment changed. Raghuvanshi pointed out a noteworthy development, pointing to a decline in concerns about international quality after July 2023. In the past, events like the Gambia cough syrup controversy—in which children died as a result of subpar products—have highlighted the critical need for regulatory changes and more monitoring throughout the pharmaceutical industry.
In reaction to persistent difficulties, CDSCO has broadened the scope of its audits to encompass clinical research organizations (CROs) and public testing laboratories in addition to manufacturing sites. The goal of this all-encompassing strategy is to provide thorough quality control at every stage of the pharmaceutical ecosystem, from development to testing and research. As part of these efforts, about 600 units have been inspected, demonstrating the scope and severity of regulatory interventions.
In the future, CDSCO intends to step up its supervision even more by launching audits of major pharmaceutical companies on July 1, 2024. The primary objective of these audits is to verify adherence to the most recent Schedule M guidelines, which delineate the requirements for good manufacturing practices (GMP) in the pharmaceutical industry. These audits are targeted at about 250 organizations, which demonstrates the regulator’s dedication to improving industry standards and reducing the risks associated with non-compliance.
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MEDICAL DIALOGUES
