India – India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule M

India is planning to overhaul its legislation on good manufacturing practices (GMPs). The draft text draws heavily on the World Health Organization’s (WHO) GMP guidelines and thereby stands to bring India in line with global standards.

Today, the structure of India’s GMP legislation, Schedule M, and the language it uses are distinct from comparable documents used elsewhere in the world. Recognizing the downsides to divergence in a global industry, Indian officials have discussed moving closer to international standards for several years. Now, with India looking to boost exports, the government has proposed a new approach.

Aside from minor wording differences, large sections of the draft legislation are identical to the GMP document adopted by WHO. That means the draft covers key concepts absent from the current version of Schedule M, such as pharmaceutical quality systems and quality risk management…