Pharmaceutical Regulatory Environment

Guidelines on clinical trials for import and manufacture of new drug were introduced in the Drugs and Cosmetics Rules as Schedule Y in 1998. This heralded the entry of clinical trials organization like Quintiles into India and encouraged the pharmaceutical industry to conduct phase III trials. Ethical Guidelines for Biomedical Research on Human subjects was brought by Indian Council of Medical Research (ICMR) in 2000. Good Clinical Practices were adopted by India in 2001 by Central Drugs Standard Control Organization (CDSCO). The National Institute of Medical Statistics of ICMR also set up a clinical trails registry in 2009. A new amendment to the Drugs & Cosmetics Act is seeking to replace the Central Drugs & Services Control Organization (CDSCO) with the Central Drug Authority (CDA) comprising of Drugs Controller General of India as the chairman and five other members. Ten departments will be controlled by the authority include regulatory affairs, imports, new drugs, biotech products, pharmacovigilance, medical devices and diagnostics, organizational services, training, quality control and legal & consumer affairs. Moreover new bill for regulation of medical devices industry is also in the gambit. Medical Devices Regulatory authority is a body; government is yet to implement to regulate the ballooning medical devices industry whose products are largely approved in other countries and eventually finds entry into Indian market.

Over the years, the European nuclear medicine/radiopharmaceuticals market has witnessed various advancements in radiopharmaceuticals. The European radiopharmaceuticals market is witnessing growth owing to an increasing number of radioisotope approvals for different clinical indications. Tc-99m and F-18 radioisotopes are estimated to contribute the highest to the European nuclear medicine diagnostic market in 2015, whereas Ra-223, I-131 and Y-90 ensured their leading position in the therapeutic market. The European nuclear medicine/radiopharmaceuticals market is expected to reach $1.62 Billion by 2020 from $1.09 Billion in 2015, growing at a CAGR of 8.2% from 2015 to 2020.

  • Regulatory review process
  • Quality measures
  • Current status of the common technical document
  • Current status of drug safety and pharmacovigilance

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