Question : EXPORT OF DRUGS

(a) whether the growth of exports of drugs has declined during the last one year as compared to previous two years and if so, the details thereof and the reasons therefor;

(b) whether there has been reports of export of spurious/counterfeit drugs and concerns have been raised about the quality of pharmaceutical products manufactured in India for exports;

(c) if so, the details thereof along with the reaction of the Government thereto;

(d) whether the Government has made any investigation in the matter and if so, the details thereof along with the outcome of the said investigation; and

(e) the steps taken/being taken by the Government to ensure the quality of drugs manufactured and exported from the country?

Answer given by the minister

THE MINISTER OF STATE IN THE MINISTRY OF COMMERCE AND INDUSTRY (DR. D. PURANDESWARI)

(a) : Madam. The exports of Drugs and pharmaceuticals has not declined as per details given below :

(Figs. in million US$ )
Year	2010-11	2011-12	2012-13
Exports	10,725	13,281	14,590

However, the growth rate of exports was 19.2%, 23.34% and 10% during 2010-11, 2011-12 and 2012-13 respectively.

(b) to (e) No case of exports of spurious/counterfeit drugs from India has been reported. However, Pharmaceutical Export Promotion Council has stated that in the recent past, there have been reports about adverse decisions taken by International drug regulators like USFDA, MHRA against some of the Indian companies like Ranbaxy, Wockhard, Sun Pharma etc. However, as per media reports /press releases by the companies, it is noted that the issues relate to integrity of data and do not relate to quality defects. Data Integrity is also a critical requirement imposed by some of the international drug regulating agencies like USFDA, MHEA etc.

Question : EXPORT OF DRUGS

Answer given by the minister

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