Just when I thought things were getting a bit dull, they go and do this.
A few weeks ago, I got a call from the Editor of Quartz India. Sruthijith was surprised (shocked?) that his go-to-drug for cold was actually withdrawn elsewhere for safety reasons. Could I explain why it was okay for Indians to consume medicines that other countries balked at?
Now drug safety as some of you might have noticed over the years, is a bit of a pet peeve with me. But after working myself up time and again over it, I began to feel a bit like a stuck record. Now I only keep my fingers crossed and pray. (No, an activist I most definitely am not). I almost visibly slumped when I heard what he wanted. But then I roused myself. Surely, this was an opportunity for many reasons. The most important : more people read Quartz India than they do Apothecurry. But seriously, it was great that a general news website was interested in carrying an explanatory piece on drug safety. And without any horrifying news trigger like deaths or disabilities. Just because it is an important issue.
So I tried. I was warned, in no uncertain terms, to keep it simple and easy to understand for a lay audience. Now, as Somerset Maugham pointed out “To write simply is as difficult as to be good.” To my rescue came the words of Fortune magazine writer Sheridan Prasso whose writing workshop I once attended. “Write so your mother-in-law can understand.”
The result is here. It is lengthy and my thanks to Sruthijith for sparing the cuts. Many of you are from the drug industry and so won’t find any surprises here. But perhaps you could share this with your moms or mothers-in-law. Don’t give me their feedback though. I am a coward and experience has taught me they are ruthless.
Late last month, the Maharastra Food & Drug Administration wrote to the National Pharmaceutical Pricing Authority (NPPA) to include medical devices in the Drug Prices Control Order (DPCO) which gives the NPPA its power to fix drug prices. Since the NPPA has been on overdrive, recently adding 108 drug formulations to the list of 348 already under price control, this sort of development can no longer be dismissed.
Medical devices are definitely a not-insignificant part of overall healthcare cost but should their prices be fixed by the government and should it be under the same set of rules as drugs? I spoke to Ajay Pitre to understand this issue better. Continue reading
The latest round of price interventions imposed on the drug industry by India’s National Pharmaceutical Pricing Authority (NPPA) has the industry fulminating. Just when it was recovering from being all but snubbed in the Union Budget, it finds that the NPPA has quietly pulled the rug from under its feet leaving it sprawled on the floor.
After the initial shock, industry captains have probably dusted themselves off and regrouped to figure out if they can sue the NPPA to oblivion. In their position, I would. Continue reading
India’s drugs regulatory office, the Central Drugs Standard Control Organisation (CDSCO), recently issued a raft of notices on the subject of clinical trials and drug safety.
While the sheer number of them – 14 ‘orders’ dated July 3 – does raise an eyebrow or two, the communiques are noteworthy as they address issues that have turned clinical trials and drug safety in India into a lightning rod for controversy. The orders are based on a report of an Expert Committee headed by Dr Ranjit Roy Chaudhury and set up by the Health Ministry “to formulate policy and guidelines to approve new drugs, clinical trials and the banning of drugs.” Here’s my view on some of these orders. Continue reading
My latest column in The Indian Express addresses the question of drug affordability. In this column, I have argued that the new Drug Price Control Order (DPCO), soon to complete a year in existence, while a major preoccupation with mandarins and managers alike in the last few months, is not a panacea for affordability. I have used the Campaign for Affordable Trastuzumab to illustrate my point. For the article click here.
Today’s edition of the Indian Express has an edit piece that I have authored on why the government should stop repeatedly tinkering with India’s foreign direct investment (FDI) policy for pharmaceuticals.
In this piece I have argued that there is no connection between the availability of essential medicines and the FDI policy and that this repeated hullabaloo around foreign investment is taking away the focus from those factors that do, in fact, have an impact on essential medicines. Not to mention the blatant double standards that it displays towards foreign-owned companies. You can read the column here. Continue reading
In continuation of the challenges arising from the roll-out of India’s new drug pricing policy, a question has now been raised on the current National List of Essential Medicines (NLEM) that specifies the universe of drugs under price control.
“Some may argue that the NLEM is not appropriately designed,” said Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals (DoP) which administers the policy, addressing CEOs and senior executives at the annual general meeting of industry body OPPI three weeks ago. Continue reading
The Drugs and Cosmetics (Amendment) Bill, 2013, which was introduced in the Rajya Sabha on August 29, is finally open to comments from the public on wide-ranging legislation that covers the regulation of drugs, cosmetics and medical equipment. This Bill is overdue given the shambles in which the current system finds itself. Continue reading
Since January 2013, Indian regulatory authorities have announced a spate of laws and guidelines that will make a huge impact on the clinical trial sector in India.
These changes are the need of hour. If made in a pro-active manner over a period of several years, various stakeholders such as the industry, investigators and ethics committees that these rules impact, will have had adequate time to adapt to them. Instead, these changes have been reactive – in point, a reaction to the Supreme Court’s orders.
Besides, the manner in which they have been made will only serve to make clinical trials in India slow and expensive, compelling sponsors to look at alternatives.