Central Drugs Standard Control Organisation (CDSCO) wants to transform the Indian Regulatory System Stringent Regulatory Authority (SRA), as outlined by WHO and at par with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For the same, CDSCO will be involving Department of Pharmaceuticals, Department of Industrial Policy and Promotion, Department of commerce, Ministry of Health etc.
Discussions at 57th meeting of the Drugs Consultative Committee (DCC), held in Goa last month, concluded that it is vital to strengthen the drug regulatory system in the country through identification of gaps and monitoring regulatory activities, to gain the trust of the public on the system and ensure that the drugs manufactured and marketed in the country are safe and effective.
Speaking to Express Pharma, Dr VG Somani, Drugs Controller General (India) (DCGI) said, “To build confidence in the global pharma market, we want to make our regulatory mechanisms robust and accountable. This step is in-line with our PM Modi’s objective of improving ease of doing business and building a competitive business environment. Hence, we propose to make the Indian drug regulatory system into a ‘SRA’. However, it is not a simple step as it needs several ministerial approvals as well as stakeholders’ support. In phase I of this process, we will do a comparative study of different parameters between the Indian drug regulatory system and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.”
Somani also said that it is his mission to make the Indian drug regulatory system rational, robust, accountable and transparent. “I am committed to this objective and will try to execute this within the span of three years,” he added.
Commenting on the proposed step by the CDSCO, Dr RA Singh, Director, RDTL, Chandigarh said, “We follow the rules set by the Centre. We will work together towards achieving this objective as well.”