Pharma Industry In India: From Government Policies To Future Concerns

India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume, according to pharma industry experts. The country is more focused on quality of drugs and medicines. Government is also working in the same context and can be seen centering more on policy making. This is overall constructive for the healthcare sector of the country, said the experts. 

Current status of pharma industry

The current status of pharma industry in India is decent. However, there are ongoing changes in policy which can lead to confusion in business. "Government keeps on changing guidelines which may obscure manufacturers but it's a good sign also as we are moving towards better side of India. If we look at wider perspective, the world can be divided into three kinds of countries - highly regulated, semi-regulated and non-regulated. Every country has its own policy and way of dealing with the industry", said Sanjeev Gupta, Managing Director, Kusum Group of Companies. 

The Indian pharma industry gained prominence since 1970s but manufacturers were not bothered about standards that time. The scenario was diverse, anybody came up to establish plants and manufacture them. 48 years have passed now and currently the country is concentrating more on regulation of drugs.

Government policies and pharma industry

The standard of manufacturing facilities should always be retained. According to Mr. Gupta, there are many encounters which the pharma industry often faces. In this pursuit, there may be conciliations with standard of drugs. However, the government is now working more on standards.
 
"Pharmaceutical industry is not a commodity. We should be focused more on standard and quality of the product. This is what the government is doing now. Government is more engrossed on policy making. They are taking resilient decisions for the concern of pharma industry. There may be ifs and buts but government is looking forward to work on criterion more which is a good symbol", added Mr. Gupta.

"There are mammoth opportunities in India. India is a good exporter of generic business and we have also taken a big jump recently. There are many people in small towns and villages who are not getting proper medicines. Government is trying to disentangle the concerns of these locations", he further said.

Threats to pharma industry

According to pharma industry experts, standard of the drugs is the only concern for the market. There are no basic threats to pharma industry in India. 70 per cent of pharma market is generic, 9 per cent is oriented and rest 21 per cent is over-the-counter (OTC) which is acceptable.

India's healthcare budget is less. The country spends only a small part of GDP (Gross Domestic Product) on healthcare while in other countries 4-5 per cent of GDP is outlaid on healthcare. There are no threats as India is working systematically.

Future concerns of pharma industry

India should become part of PIC/S (Pharmaceutical Inspection Co-operation Scheme). The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

"All FDAs (Food and Drug Administration) are part of PIC/S which ensures that all manufacturing is part of the system as well. Small countries like Vietnam and Uzbekistan which don't even have 5 factories want to become part of PIC/S now. India is also not the part of this society. India is doing a generic business and we are contributing to around 20 per cent medicines of world. This means every fifth tablet created in India is used worldwide. In this scenario, it is important that we become part of the PIC/S. We are part of WHO (World Health Organization) reality but it is not essential for all the industry. PIC/S is more important for us. I am sure in future we will become part of the system", said Mr. Gupta.

China recently exempted import tariffs (duties) for 28 drugs, including all cancer drugs, from May 1, 2018. This may impact Indian pharma sector too. In words of Mr. Gupta, "The impact may not be immediate as people are not keen to go to China. There is language barrier and recession process is tough. It will take at least 5 years to establish."