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Pharmacovigilance

What’s in news?

  • Growth comes amid challenges of margin pressure, more regulatory scrutiny, says Pharmexcil D-G
  • India’s pharmaceutical exports grew a robust 10.72% in 2018-19, and raced past the $19-billion mark for the first time, a performance marked by a rebound in the U.S. market, improved show in almost all the top 25 destinations and across categories.

$20-billion mark

  • Exports touched $19.13 billion as against $17.28 billion of 2017-18, the previous highest, details available with Pharmaceuticals Export Promotion Council of India show. While it fell short of the $20-billion mark that was widely expected to be crossed, the performance was still special. Though pharma exports have done relatively better with the nearly 25% rise to $13.30 billion in 2011-12, the circumstances under which the latest performance came were different, Pharmexcil Director General Ravi Uday Bhaskar said.
  • Making matters challenging for exporters over the last few years has been the increased regulatory scrutiny, pressure on margins in the face of mounting competition and the need to geographically diversify the market. In the five years to 2018-19, exports had declined in one year (2016-17). Other factors such as price control in Germany, Brexit and the lockdown in the U.S. also influenced trends.

Good practices help

  • Positives for the exporters were increase in the price of APIs/bulk drugs, the health regulators classifying lesser number of cases, post inspection, under the official action indicated class that sometimes led to import alerts.
  • According to Mr. Bhaskar, improved good manufacturing practices (GMP) maintenance would have saved more mandays that otherwise would have been lost to carrying out rectifications suggested by regulatory authorities.
  • Category-wise, drug formulations and biologicals with $13.56 billion ($12.09 billion) dominated the 2018-19 exports. The 12.13% increase was the highest across all categories and took drug formulations and biologicals share in total exports to 70.87%. Bulk drugs and drug intermediates, the other mainstay of exports, was next at $3.89 billion ($3.52 billion) or a share of a little over 20% to the total.
  • Herbal products was the only segment with negative growth, while exports of vaccines, surgicals and Ayush increased.
  • Region-wise it was North America, primarily the U.S. market, that figured at the top, accounting for $6.14 billion or nearly one-third of the total exports. Compared to 2017-18, the change was 14.92%. The U.S., specifically with $5.82 billion, contributed to 30.42% of the exports.
  • In terms of their contribution to the exports, Africa with $3.43 billion and 17.96%; and the European Union with $3.03 billion and 15.70% occupied the top slots. ASEAN, LAC, West Asia markets for Indian pharma grew at a rate above the overall export growth, he said.
  • Country wise, the U.S. with $5.82 billion led the list. While the U.K., South Africa and Russia followed, the rate at which exports grew was higher to Brazil (17.81%); Canada (41.54%); the UAE (102.85%) and Bangladesh (17.79%).

https://www.iasipstnpsc.in/e-pharmacies/

https://www.thehindu.com/business/Industry/pharma-exports-grow-11-cross-19-bn/article26968156.ece

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