In order to strengthen the drug regulatory system in India, health ministry is currently in the process of studying a set of regulatory modules from regulators of foreign countries to create and set a benchmark in terms quality and good manufacturing practices globally.
Considering the fact that certain Indian companies have got critical global attention due to certain evasions, violations and avoidances during US FDA inspections in the last couple of years, government regulatory agencies have started emphasising the need to ensure consistent quality of drugs manufactured in India.
As per the plan, the dynamic exercise of studying guidelines of foreign regulators is being done jointly by Central Drug Standards Control Organisation (CDSCO) and officials from the health ministry. According to an official associated with the development, guidelines will be referred from not only from Pharmaceuticals and Medical Devices Agency (PDMA), Japan, European Medicines Agency (EMA), MHRA but also regulations existing in lesser developed countries and countries under BRICS.
“There is a growing need for drugs standardisation compliance and regulatory requirements to be at par with international regulations, including the US FDA, allowing drug manufacturers to maintain competitive advantage,” an official says.
The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK.
Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
CDSCO regulates quality standards of drugs and is also responsible for the approval of new drugs. It is learnt that a Cabinet note on upgrading CDSCO into a world-class health regulator has also been floated and the proposal may be taken up shortly. “Upgradation is a dynamic process which aims to adopt best manufacturing practices established and followed globally,” explains Dr GN Singh, Drug Controller General of India (DCGI).
The responsibilities of CDSCO include grants of import and export license, clinical trial approvals and permissions for marketing and manufacturing. State Food and Drug Administration (FDA) works with CDSCO in each state and is responsible for issuance of license to manufacture similar biologic in India apart from regulating the drug quality.