“It is a good sign that the US and Indian regulators are collaborating on inspections”

Kate Kuhrt
Senior Director, Proposition, Generics and Biotech, Thomson Reuters
Kate Kuhrt Senior Director, Proposition, Generics and Biotech, Thomson Reuters in an interview with Mahesh Kallayil discusses the evolution of Global and Indian Generic Industry in next few years.

How do you see the global generic drug industry and what role does it play in health care today?
The global generics industry is a very dynamic industry with lots of players in many parts of the world.

Generics, whether sold under brand names or under the INN name, play a huge role in the health care for a few reasons. Because their lower prices, they help to make medicines affordable and accessible to people in all parts of the world. Additionally, guaranteed competition from generics acts as a motivator for innovators to continue to come out with new and innovative drugs.

Looking ahead, what potentials do you see in the arena of generic drug industry in India?
Over the years, Indian companies have been moving up the value chain - from API manufacturing to generic finished dose manufacturing, from generic finished dose to products with barriers to entry and hopefully higher prices and higher margins, such as enhanced generics (also known as generics plus or super generics), and ultimately to developing new innovative drugs. I believe that for many companies this progression will continue. For example, many Indian generics will find opportunities in biosimilars. Indian companies are well positioned to continue to be the ''pharmacy to the world''.

How do you see the quality issues related to Indian Generic drugs? Have they been overblown?
The reputation of the Indian generics industry has definitely been harmed by the steady stream of news from the US and Europe about warning letters and data integrity issues. The mindset among Indian companies needs to change - Regulatory compliance needs to become part of the DNA of the industry and not just something you do when inspectors are looking. This will, no doubt, take some time.

Do you think that the law has achieved its objective of increasing the use of generics and improve access to medicines for the poor?
Without knowing the intricacies of the law (for example, were there goals in place to increase the usage of generics by a certain percentage?) it is difficult to answer this question. Clearly, there are still many people in India for whom even today's generic drugs are out of reach.

People still prefer to buy a branded product rather than a generic. Why do you think the masses have still not entirely accepted the generics?
In many markets, generics are sold under their own brand names. Many Indian companies have strong brands and are capitalizing on those brands. So, it is possible to prefer a brand and still buy a generic product. Ultimately, I believe that a decision around whether to buy a branded or non-branded drug comes down to trust.

Counterfeit or spurious medicines are supposedly a huge problem in developing countries. How will this affect the Generic drug manufacturers and could they address this problem?
Counterfeits affect generics in a few different ways. For example,
1) To the extent that some patients end up inadvertently taking counterfeit medicines, the generic companies miss out on drug sales opportunities.
2) In order to fight counterfeiting, regulators are introducing "track and trace" types of requirements which increase the manufacturing, packaging, distribution, and information management costs for generics.

Could you throw some lights on regulatory landscape for Generic players in US, Europe and other emerging markets?
Regulations across the globe are getting tougher."Track and trace" type rules that track a package of medicine from the production line to the patient are being instituted in many countries. This will add costs to packaging, labeling, and information management.

In the US, GDUFA (Generic Drug User Fee Act) is a key regulation that instituted fees for facilities and individual filings, such as drug master files and ANDAs. The combination of the fees, long drug approval time lines, and high expectations of the FDA is keeping many new players out of the US market.

May we have your thoughts on current regulatory scenario of Indian Generic drug market?
Regulatory was front and center in the recommendations of the task force for enabling the growth of private enterprise. So, clearly, the trade organizations and government appreciate that if the Indian generics industry wants to grow and increase its exports, it needs to bring regulatory to the next level. It is a good sign that the US and Indian regulators are collaborating on inspections.

Is there anything that you would like to see from policy and law standpoint that would be helpful for growth of Generic market in India?
Per capita health care spending in India continues to be very low.

So, policies that encourage increased spending on healthcare would likely also increase the size of the domestic generics market.

What constitutes a winning strategy for Generic players to stay competitive today and in the future?
I believe that over the coming decade, in order to stay competitive, generic companies need to excel at:
  1. Product selection - nobody can do everything, so companies need to be strategic about the products that they pursue.
  2. Market selection and market entry s t r a t e g y p l a n n i n g - many Indian companies are focused on exporting. However, different countries require different market entry strategies. Do you acquire, partner or build your presence from scratch?
  3. Cost management - generics are very cost conscious. That being said, it is short sighted to look at only the cost of manufacturing or cost of the active ingredients. If your product launch is delayed because of regulatory issues or supply chain issues, any "savings" will be wiped out.
  4. Partner selection - generic industry supply chains are very complex, with lots of different players involved in making intermediates, active ingredients, excipients, dossier filings, marketing. Each transaction point introduces new risks into the supply chain. This takes us back to the previous point. A mistake made during the partner selection process could have disastrous consequences to the company.
  5. Regulatory - authorities across the globe are making their regulations tougher. In order to comply with many and at times conflicting regulations of countries across the globe, generic companies will need to be efficient in how they access, maintain, and disseminate within the organization regulatory information.