Delay in clinical trials approval affecting pharma sector

GV Prasad, chairman and CEO, Dr Reddy's Labs says, “Clinical trial pathways are unclear and there is a lot of subjectivity involved in approvals. Even today, to get bio-study or a bioequivalence study done is a problem. Even for generic drugs we are now doing studies outside India. It is a big challenge.”

Dilip Shanghvi, MD, Sun Pharma says, “Most of our first and second phase of clinical trials for SAPRC products, we are talking of doing outside India. That is because getting clearances and approvals take time. So even though we can do equally good trials in India, we are doing wither in US, Europe or Canada.”

Experts agree that the extra scrutiny is warranted. After all, it started when some clinical trials went wrong at the human testing stage and there is hope that the guidelines on trials and patient-compensation will be finalised soon. But that's not the only problem drug companies are facing. Some of the old concerns regarding drug pricing and intellectual property continue to keep drug-makers cautious about the India story, especially the foreign drug developers, who feel policies need to be strengthened.

According to Sanjiv Navangul, MD, Jannssen India, Jannssen brought drug resistant TB drug. That is highly beneficial for India as it has the largest burden of drug resistant TB. Now the follow-through is important and so, now that we have the drug, the government needs to collaborate. Industry needs to say it is great innovation, leave the innovator alone.

But some players still hold out that India is not alone in setting a drug-pricing policy and right pricing is drug-maker's responsibility too.

Prasad adds that pricing is not an EM problem. Even Europe, US are finding solutions that suit them. For example, Merck launched Januvia through differential pricing strategy and it has worked.

Rogerio Riberio, Sr VP - Emerging Mkts, GSK says, “IP should not be a barrier in access of medicine. Even before you start development of a drug, you should start assessing how it will be made accessible to the population.”

Others, though feel, industry should be more proactive.

Praveen Tyle, chairman and CEO, Osmotica Pharma says, “Role of government is there but the industry should start the dialogue.”

And times are changing as government and drug firms engage together to set aside hurdles and find a middle ground for a thriving drug industry and health for all.