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The Pharmaceutical Quality System mandates manufacturers to assume responsibility for the quality of pharmaceutical products to ensure that they are fit for their intended use and do not pose any risk to patients due to inadequate safety, quality, or efficacy.
The new guidelines come against the backdrop of deaths reported in certain countries such as Gambia in Africa that were linked with consumption of Indian drugs | Latest News India
Pharmaceutical companies having an annual turnover of over Rs 250 crore will have to mandatorily adopt Good Manufacturing Practices (GMP) within six months, Union Health Minister Mansukh Mandaviya said on Wednesday.
India is a major exporter of medicines to LMIC (Low and Middle-Income Countries) which require WHO GMP certification. There are around 2,000 units in the MSME category in the country having WHO GMP certification.
Get latest articles and stories on India at LatestLY. Good Manufacturing Practices (GMP) is mandatory standards which builds and brings quality into the product by way of control of materials, methods, machines, processes, personnel and facility and environment etc. India News | Pharma Companies with More Than Rs 250 Crores Turnover to Be Given 6 Months to Adopt Good Manufacturing Practices: Official Sources.