The Pharmaceuticals Export Promotion Council of India (Pharmexcil), under the ministry of commerce and industry, is working on a zero dependant manufacturing mechanism in order to reduce the dependancy on imports. The ministry, through Pharmexcil, has formed a committee which is in the process of identifying those drugs which are imported in huge volumes from other countries. Incidentally, pharma exports have fallen marginally from $16.8 billion to $16.4 billion due to price erosion and currency fluctuations across few key markets.
Zero dependant mechanism, as the council calls it, translates to not depending on raw materials from other countries. India imports drugs and pharmaceutical products from Europe and China in the form of raw materials as well as finished products for both domestic consumption and exports. The country is currently importing about $3 billion worth of active pharmaceutical ingredients (APIs) and intermediates chemicals from China and the idea is to cut down the dependence on Chinese imports and boost local manufacturing.
“We are working to reduce the burden of bulk drugs or APIs which are imported from other countries,” Ravi Uday Bhaskar, director general, Pharmexcil, said. Imports form a big portion of many common drugs such as painkillers like Aspirin and Paracetamol, first-line diabetes drug Metformin and antibiotics such as Erythromycin. The Centre is looking at various initiatives to boost domestic bulk drug manufacturing. These include bringing down the price of input costs to providing infrastructure to boost the industry.
“Over-dependence on imported pharma raw materials from Europe and China to meet the growing requirements of drug formulations is a cause of concern for the industry as well as policymakers,” Bhaskar added. “In the process, we will be roping in scientific research institutes for a strategy to make zero dependant industry which could possibly take some time. We are working with laboratories such as Indian Institute of Chemical Technology (IICT), Hyderabad, National Chemical Laboratory (NCL), Pune and industry bodies such as Bulk Drugs Manufacturers Association (BDMA) and Indian Drug Manufacturers’ Association (IDMA) to understand about those top 100 products, which are currently imported, but can be manufactured in India,” he said further.
On pharma exports, Bhaskar said that there was a marginal fall at $16.4 billion for March 2017. “There is not much significant growth in pharma exports during 2016-17 compared to exports worth $16.89 billion during 2015-16. This was primarily due to price erosion in the US market, absence of any blockbuster drugs and currency issues in the African markets. Incidentally, two blockbuster drugs had gone off-patent during April-November 2015 — Aripiprazole and Esomeprazole — which led to a lot of value to exports. We expect 30% growth in the next three years,” he added.
According to Bhaskar, the pharma sector is set for a quantum leap and India can reach $20 billion exports by 2020.
“The domestic pharma sector is set for a quantum leap. There are about 700 drug manufacturing units registered with the US Food and Drug Administration (USFDA) and over 30% of abbreviated new drug applications (ANDAs) granted by the USFDA in 2016 were from India. We are hopeful of achieving a double digit growth and reach $20 billion exports by 2020.”
The Indian pharmaceuticals market is the third largest in terms of volume and 11th largest in terms of value. Besides, the country is also the largest provides of generic drugs globally with the Indian generics accounting for 20% of global exports in terms of volume.
On the impact of the recent USFDA inspections on the domestic companies, Bhaskar said that since the country is home to a lot of USFDA-approved plants after the US, it is natural to have more inspections and Indian companies have to gear up to meet the compliances as 35% of the total exports is to the US markets.