Administrative Structure and Functions of Drug Regulatory Authorities in India

The legal basis for the enactment of the DCA was Section 103 of the Government of India Act 1935 (equivalent to Article 252 of the Constitution in terms of legal effect). [...] As per the DCA, the DCC is an advisory committee to advise the central government, the state governments and the DTAB on any matter tending to secure uniformity throughout the country in the administration of the DCA. [...] For instance, to harmonise the regulatory performance, it was resolved in the special DCC meeting held on October 27, 2014, that the SDRAs will also adopt the same mission and vision statement, as that of the CDSCO, i.e., “To [sic] safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.” Nevertheless, the functioning of the DCC. [...] The corresponding law in the EU is Article 55 of Regulation (EC) No 726/2004; in Indonesia, it is the Decree of the Head of the National Agency of Drug and Food Control, 2011, and for China, it is the Drug Administration Law of the People’s Republic of China. [...] Therefore, the aim of the paper is three-fold, first, to suggest the criteria for assessment of the pharmaceutical regulatory regime in India; second, to examine the suitability or appropriateness of the present regime in terms of these criteria; and third, to suggest a possible basket of measures that could be explored to strengthen the present regulatory regime.