New Delhi February 12, 2014:- Regulations in the Indian pharmaceutical sector are under the scanner. These have come under fire after the US Food andDrug Administration (FDA)’s alleged non-compliance by manufacturing units, while they also deal with strict clinical trial guidelines at home, set by the Supreme Court. Yusuf Hamied, chairman of Indian drug manufacturer Cipla Ltd and a veteran in the pharmaceutical industry, talks with Antonita Madonna about the regulatory framework in India and advocates “pragmatic” changes. Edited excerpts:
What are your views on the anxiety in the drug manufacturing sector after the US FDA banned drugs from certain Indian manufacturing units?
Let them not buy from us, then (if they are not satisfied). Today, 50 per cent of the drugs sold in the US comes from India but they can’t manufacture. There are basic rules and, I believe, you have to abide by the laws of the land. If America has its rules, we have to abide by their rules without a compromise. However, I must know what those rules are. If you change the goalposts every few months without informing me, how will I know? It is very important for the US government and the FDA there to notify and update us as and when they change rules. Then, we can be held responsible. But to be so rigid is their call. To each his own.
Won’t a decision like this have a detrimental effect on the safety perception of drugs manufactured in India?
We are not looking at the big picture. Of 120 warning letters issued by the US FDA, only six have been to Indian companies. What about the Johnson & Johnson factory being shut in the US? Even Teva, Pfizer and Glaxo(SmithKline) have been prosecuted. I’m not saying Wockhardt or Ranbaxy or some of us don’t make mistakes. But so do the others.
Is there a rising fear among developed countries that India is taking over drug manufacturing? How do you suggest India handle it?
They are jealous like hell. We can handle this by having a pragmatic policy. The policy should give us proper infrastructure. If Indian companies are stable in the home market, we can take on the world. Being stable in the home market means there should be a reasonable price level. Many leading Indian companies’ products are under price control but the multinational corporations do not have any price control. The simple pricing structure I suggest is no price control over drugs more than 20 years old; drugs made in India by more than five people need not be under price control because competition will bring down prices. The last aspect is drugs sold monopolistically should be placed under price control.
Roche recently secured an order preventing Biocon and Mylan from marketing their new drugs as biosimilars of Roche’s innovator breast cancer drug.
It’s shameful and scandalous. The matter is in court, so I can’t comment on that. But keeping the companies aside, my general opinion is when a company comes to India, it has to abide by Indian laws. The Indian FDA has passed a drug with whatever data was available. What is the problem? I think Roche is just getting undue publicity and putting a doubt in the minds of doctors that another company’s products are not as good as theirs.
ALSO READ: Biocon squares up against Roche claims on cancer drug
A large section of the biotechnology sector has been voicing their opposition to the tough guidelines for clinical trials in India. What is your view?
In the past two years, 1,800 Indians died due to faulty clinical trials. There is a Drug Technical Advisory Board in India that passed a rule in the mid-1960s stating no preliminary drug trials will be allowed in India on drugs developed abroad, unless the drug is marketed in two developed countries. If the Americans develop a drug or if the French do, let them do the trials on their own countrymen. Why on Indians?
But a drugs to be tested on Indians in order to be found suitable for the gene pool here..
There was a provision (in the 1965-rule) that if the drug is already being marketed in two countries, then clinical trials could be done in India to compare them and fix the dosage for Indians. But for drugs invented in india, everything was allowed. That was law in India from about 1965 but then a change in rules – which in my opinion was disaster – allowed initial trials in India if the protocol for those trials are approved in any two countries. So these companies got the protocols approved by say Romania or Czechoslovakia and brought those protocols and got approvals to conduct trials in India.
In India there is a lot of wheeling and dealing and influence and worry about upsetting the international community. Why not use their own countrymen as guinea pigs , why use Indians? How did AIDS come to Africa? Faulty clinical trials. That’s my personal opinion and I’m an expert on HIV.
However, Indian companies say they get caught in the line of fire too and either have to stall drug development projects or move it outside the country at significantly higher costs?
Its not much about the cost, but the regulations. So far the world has not yet harmonised what should be the rules and the regulations under which you approve biotech drugs.
Why not let the people who are experts in that decide? Let the Indian FDA decide. The Supreme Court is there to check if a law has been misinterpreted or not. But they are now interfering with a lot of matters that are not their concern.- Business Standard
