Government of India to tighten quality mechanisms in pharmaceuticals
September 29, 2014: The Government of India is planning the largest nationwide survey to estimate the extent of sub-standard and spurious drugs in the country apart from a series of measures to cover the gaps on quality of drugs in circulation in the country and overseas.
The steps to improve quality are expected to include measures like mandating pharmaceutical companies to print prescribed storage conditions on the label, urging state drug regulators to undertake time-bound follow-ups of specific quality related complaints from other countries. Additionally, the Government is also working on a pilot project on working out the modalities of barcoding on drug packs to ensure authenticity.
India is one of the first few countries to launch the Trace and Track mechanism for its pharma products. The system involves affixing barcodes on the primary, secondary and tertiary levels packaging labels in phases following GS-1 global standards. The barcode helps in tracking and tracing the origin of drugs, which in turn minimises the chances of genuine drugs being considered spurious, sub-standard or counterfeit.
With a sample size of over 40,000 drugs, the survey proposed to be designed by the Indian Statistical Institute, Hyderabad, working with National Sample Survey Office (NSSO), would zero in on the geographies with high concentration of spurious or sub-standard drugs, which may need an intensive action plan to monitor the trail of such drugs. The drug samples would mainly be essential drugs of 15 therapeutic categories enlisted with the National List of Essential Medicine.
The recent initiatives by various stakeholders to improve the quality mechanisms in India’s pharma industry are expected to improve the perception of Indian pharmaceutical industry.