In yet another proactive action to ensure the quality, safety and efficacy of the drugs marketed in the country, the drugs controller general of India (DCGI) has directed the pharma companies in the country to bring details about drug import alert or restrictions imposed by regulatory authorities abroad to the immediate notice of DCGI office as well as the state drug control authorities.
The DCGI's action comes in the wake of the fact that recently some concerns have been flagged in some countries with regard to the issues related to compliance to good manufacturing practices (GMP) and other aspects in manufacturing of certain drugs by some Indian drug manufacturers and exported to these countries. Restrictions like import alerts have also been issued in certain cases. Such actions have been taken by the drug regulatory authorities abroad in light of the regulatory requirements in those countries. Such Indian drug manufacturers are also involved in manufacturing and supplying the similar drugs to the Indian market. India is exporting drugs to more than 200 countries.
“In view of above, it has been considered necessary that such issues, as and when raised, be brought to the notice of regulatory authorities in India so that necessary action is taken to ensure the quality, safety and efficacy of the drugs marketed in the country,” the DCGI in his directive to the state drug control authorities said.
DCGI Dr GN Singh in his directive asked the state drug control authorities to direct all the manufacturers in their respective state to union territories that, as and when such issues are raised and actions like restrictions or alerts are issued by any drug regulatory authorities abroad in respect of drugs manufactured and exported from India, the details of the same should be brought immediately to the notice of the office of DCGI as well as the state drug control authority concerned so that its impact in Indian scenario can be assessed and necessary action can be taken to ascertain the quality, safety and efficacy of the drugs available in the country.