What’s wrong in govt consulting industry for policies?

 

Last week the famous whistle blower in Ranbaxy data fudging case wrote in Scroll that the Indian drug regulator is “inept” in regulating biosimilars, a new class of drugs that have come to dominate the market and will increasingly do so for the next decade.

 

Dinesh Thakur certainly has a point but it is known for years that the Central Drugs Standard Control Organization is severely understaffed and underfunded to acquire technical expertise required to regulate the drug industry as a whole. What is also certainly

over-the-top in his opinion piece is the comment that the industry “has set” the standard for biosimilars in India, and as a result, he implies, the standard is lower. The committee which drafted the guidelines indeed had wide representation from the industry and why not. It happens in most sectors where inevitably industry is ahead with the technology, be it semiconductor, solar, or automotive. Even in the most stringent healthcare market of United States companies like Amgen work “with” the FDA to set guidance.

 

The expert who was at that table and who wrote a third of the biosimilars guidance, and DBT writing the rest, says industry drives the agenda and policy in all countries and it is wrong to say they “set” the standards in India. Professor Anurag Rathore at Indian Institute of Technology in Delhi chairs the committee that advises the drug regulator on biotech products and has held several training sessions for the government as well as the industry.

 

The trouble with the guidance though, says Rathore, is that the way it was drafted CDSCO did not take ownership of implementation. As a result it remains just guidance. That is not surprising because most healthcare guidelines in India remain toothless. (Stem cells therapy is a classic example where clinics in nooks and crannies peddle all sorts of cures and no one can book them under law.) Rathore and CDSCO are now updating the guidelines.

 

Now back to the question of why the industry is being consulted when the guidelines are still discussed. In the mid nineties when K Varaprasad Reddy, an electronics engineer by training, took upon himself the improbable task of developing recombinant products, Hepatitis-B vaccine in particular, he would go from officer to officer in the health ministry in New Delhi requesting them to upgrade their pharmacopeia so that the recombinant products his company Shantha Biotechnics was making could be regulated. He worked with the Department of Biotechnology even then. No lab in the country at that time made even pilot scale human recombinant products. Was he setting the standard?

 

In fact, after Shantha’s product Shanvac was launched in 1997, the Department of Biotechnology brought out the guidelines for “generating pre-clinical and clinical data for recombinant DNA based vaccines, diagnostics and other biologicals” in 1999, ten years after the first ‘Rules of 1989’ were laid down. By Thakur’s logic, Varaprasad should have waited several years. In that case, what came first – the product or the guidelines? It’s seen worldwide, innovation is miles ahead of policy and biosimilars is no exception. (A few more examples in my forthcoming book from HarperCollins.)

 

The second point I want to make is that because biosimilars are such complex products, the investment required in the manufacturing plants is several times more than the regular small molecule drugs, it’s pure economics that would drive the companies to follow good standards so that they can sell these products in other markets as well. For a country that spends under two percent of its GDP on healthcare, and with a totally broken public health system, the domestic market is just not big or lucrative enough for Indian companies to invest in making biosimilars. If a few companies are making it, they have their eyes set on global, or at least, the emerging markets. And since biologics are made from living cells, no Indian company can easily set up plants in other regions as it routinely does in synthetic drugs. In short, it’s in the interest of the industry to have good standards in India.

 

Granted that Intas pulled back Razumab drug from the market, but it’s also true it was the first Indian company, and is still one so far, to sell a biosimilar in the European market. If Biocon-Mylan’s trastuzumab quality is suspect, as Thakur implies by citing Roche’s case, the molecule would not have reached Phase III global trial, envy of some big pharma-biotech alliances racing to take this biosimilar to the market.

 

The fact is Indian traditional generics makers as well as the drug controller underestimated the complexity of developing biosimilars; however, both are making small amends toward that. CDSCO needs to hire people with expertise and experience from the industry, it still hasn’t done it. “The problem in India is people from academia and industries do not want to work in regulatory agencies. In the US, people seamless move from FDA to industry to academia, it should happen here as well,” says Rathore.

 

Six years ago when he moved to India from Amgen, he wanted to work in an area that would help improve processes in biotech industry. He now runs a DBT-supported Centre of Excellence for developing new technologies of biotech products so that they can be transferred to the industry to lower the cost of products. “We are trying to focus on the quality of drugs, what is truly important and take up a few key parameters in our research. Our goal is to raise the standard of our industry.”

 

 

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