The API manufacturers in India are trying to strengthen their marketing in regulated markets by different means viz., by focusing on the improvement of production yields; especially of critical products, through process modification; by increasing the productivity of high volume products; by escalating sales in international market; by introduction of high potency API used in oncology; etc. Manufacturing standards in India are acquiescent with many international regulations. In addition, innovation in the technological capabilities of the country has enabled many manufacturers to endeavour into the highly regulated markets of the US and Europe.
The global demand for active pharmaceutical ingredient (API) market was valued at US$ 148.22 billion in 2015, is expected to reach US$ 213.84 billion in 2021 and is anticipated to grow at a CAGR of 6.3 per cent between 2016 and 2021, according to a report by Zion Research.
The market for API is expected to have the highest growth rate in the forecast period. However, strict regulations are one of the major challenges faced by the global API market. Such regulations are predominantly well defined in developed regions such as North America and Europe. Vendors in this market space are supposed to obey the detailed procedures prior to product commercialization.
The branded drug segment accounted for the largest share in 2015.
Different therapeutic application of the API market includes cardiology, oncology, anti-inflammatory, gastrointestinal and others. The oncology segment is anticipated to grow at the highest growth rate in coming years due to increasing prevalence of cancer worldwide.
Indian API industry will now get a booster shot as the government plans a slew of supportive measures. The government is expected to give more impetus and secured business for the indigenous industry.
In order to ensure robust growth and provide more scope for developing the sector, we are working to give further fillip to the API sector, said Minister for Chemicals and Fertilisers Ananth Kumar.
The Ministry of Chemicals and Fertilizers had christened 2015 as the Year of API and the Government of India (GoI) is taking significant steps to foster this initiative. A task force known as the Katoch Committee has been constituted by the department of pharmaceuticals (DoP) to promote bulk drug manufacturing in the country. Six large API intermediate clusters in 5-6 states are being established to revive API manufacturing in the country.
On the inverse duty structure and on the levy of 12.5 percent excise duty on bulk drugs, Minister Kumar said “What every tax hurts the industry including the inverted tax is removed. We are also taking care of our Free Trade Agreements (FTAs) with different countries. Whatever is not favourable to the Indian trade and industry, our government is pursuing Make in India.”
The government of India is sensitive on the issue of FTAs which covers the Far East countries. Now it is a phase of action. We are coming out with pharma parks and bulk drugs parks in the country,” Kumar said.
Katoch Committee for bulk drugs focussed that most of the business has gone to China. Therefore India has to retrieve that business. India about two decades ago was the main pharmacy for bulk drugs. So the government is now making efforts to set up bulk drugs parks. Once we establish the bulk drug parks with all the common infrastructures, it will give the industry ample support to take-off. The government is doing it, said the Minister.
This support by the government will now see promising growth prospects to candidates. For instance, in the case of Pharmacy Training Institute, it is a platform for skill enhancement and achieve faster chances of getting placed in the pharma industry.
For instance, over 560 students from 32 batches have been placed in both in India and abroad. The syllabus for training has been revamped to suit the current requirements covering from production of API, formulations, to regulatory affairs or end-to-end supply chain, sales, human resources and finance, said Uma Nandan Misra, dean, Pharmacy Training Institute (PTI), Bengaluru.
The demand for total continuous quality management systems has led the need to add on application of microbiology in pharmaceutical testing, calibration of instruments, packing material analysis and drug recalls. It is also mandated to have a practical experience in an approved Drug Testing Laboratory to comprehend the nuances of analysis. Pharma industry is increasingly focusing on scientific marketing skills added Misra.
Drastic manufacturing cuts implemented by the pharma giants to in-house API production owing to poor cost viability and productivity issues coupled with other key parameters such as high end R&D costs and pricing issues on finished formulations have resulted in a thrust to outsource API production. Such outsourced manufacturing activities are carried out by low-cost vendors in the Asia Pacific region. Moreover a substantial upsurge in the demand for generic prescription drugs will also help to accelerate API production.
The highly profitable biological API segment is experiencing positive spikes in response to a concerted interest evinced by the Big Pharma. Oncology API comprising of high potency active pharmaceutical ingredients (HPAPIs) is an area of avid interest and is expected to be a major growth driver of API market worldwide.
The Union commerce ministry is set to device an action plan to reduce dependence on China for import of APIs by Indian pharmaceutical firms.
As part of this, a preliminary meeting chaired by Sudhansu Pandey, Joint Secretary, Ministry of Commerce, sought suggestions and ideas to device a strategic planning from all the stakeholders of pharmaceutical industry, research institutes and bulk drug manufacturing association.
“Recent meeting held by Commerce Ministry was attended by Director, Indian Institute of Chemical Technology (IICT), chairman of Bulk Drugs Manufacturers Association (BDMA) and Pharmexcil to discuss on the issue of overdependence on China for import of APIs. We have submitted our views about the pharma industry. The ministry has sought more information about Key Starting Materials (KSMs) and APIs being imported by the member companies from China and other countries,” informed Uday Bhaskar, Director General of Pharmexcil.
Challenges for API industry:
India needs a dedicated bulk drug park. This area should be formally approved by the Ministry of Environment to bring the state pollution control boards to certify that the area is fit for its production. This is because the biggest issue is pollution control board clearances. These issues are perpetual and time consuming because approvals are cumbersome and not coming through. But drugs need to be treated differently where a large area is to be given with a 5 or 10 kilometre buffer around the manufacturing plants of APIs so that no other industry can come up there. Even in Malur Industrial Area where a bulk drug unit exist are now facing issues where other industries complain about the pollution and environmental hazards.