“Just as we undertook the risk-based assessment of (drug) manufacturers to ensure good laboratory and manufacturing practices, there will be inspection of stockists as well,” said the official.
Last year, 27 drugs manufactured by 18 major pharmaceutical companies failed the quality test. Risk-based assessment is a concept India has borrowed from the United States of America.
The Centre and states are working together to undertake the risk-based assessment. Companies that have been receiving multiple complaints from state drug controllers have already been rated high risk. In order to conduct these assessments, the Central Drug Standards Organisation plans to recruit 500 inspectors by the end of this year.
Indian companies export drugs to about 200 countries. The World Health Organisation (WHO) also procures about 60 to 70 per cent of its vaccines from India. This has put Indian drug exporters under the scrutiny of global drug regulators, including the US Food and Drug Administration.
As they highlight the shortcomings in Indian drug makers, the local governments have come under pressure to maintain quality.
The Indian government is also drafting a policy on good manufacturing practices in accordance with WHO standards.