’Maharashtra is the hub of quality medicines’
Describe the pharma sector in Maharashtra.
Drugs and Cosmetics Act,1940, The Drugs and Magic Remedies (objectionable advertisements) Act, 1954 and Drugs Price Control Order are the main statures which go in a long way to supply quality medicines and cosmetics as per the requirements of the patients. Patients should not get spurious medicines and of course the same thing is applicable to cosmetics also. These are the main things for which FDA functions. FDA also functions as a regulator for manufacture, distribution and sale of medicines and cosmetics. When it comes to the manufacture of medicines, Maharashtra is the major contributor. Earlier, we used to contribute about 70-75 per cent of the total medicines manufactured in the country. Now it has come down to 24-25 per cent. But the main strength of Maharashtra is that we are very quality conscious. We make the manufacturers follow the Schedule M which is the SOP for GMP to bring out quality product. We need to be quality conscious while supplying medicines in the country and to get international attention. We collect around 6000-7000 drug samples annually from the market in the state, out of which around seven per cent are found not to be of standard quality . If you further analyse this, 14 per cent of these are manufactured outside the state and only three per cent are manufactured in the state. Quality aspect is much better in Maharashtra compared to other states in the country.
Maharashtra also contributes in a bigger way in the export of the medicines. You will find that US FDA approved plants in the country are more in Maharashtra than any other state. Maharashtra is the hub of quality medicines. We further want to expand our base. As the incentives given by other states are taken away, we believe that pharma companies would again migrate to Maharashtra. We have a good climate, availability of water and electricity and most importantantly quality manpower.
Was the tax incentives the only reason for which pharma companies were migrating towards other states?
Yes, it was. Now, as incentives are over, pharma companies will again look at the places where there is more peace and industry-friendly environment. In Maharashtra, quality aspects are also looked into, the state is known for it.
What are the unique challenges associated with FDA Maharashtra that other state FDAs may not have to face?
The pharma sector in Maharashtra continues to remain the most productive and quality conscious in the country. For us, challenge is to regain the position where we had 74-75 per cent manufacturing base in the state. We are trying to promote the industry in collaboration with MIDC and other departments.
Now-a-days it is very often said that Maharashtra is losing or has already lost its leadership position in the pharma sector. How true is that?
Those who claim so are perhaps ill-informed. There is no data to show that this is happening. In fact, maximum number of WHO-GMP certifications are going from Maharashtra. US FDA approved plants are more in Maharashtra. There are MHRA approved plants in the state. So the statistics show that Maharashtra still has a grip over the pharma industry. Maharashtra hosts 10 per cent of country’s population. Geographically also we are just 10 per cent of the country. Despite this we manufacture about 24 per cent of country’s pharma output.
Clinical trial industry is moving out of India. What is your view on this?
This is a wrong perception. In fact, clinical trial is not a state subject. If you read information available on the Internet, developed countries are losing out on clinical trials. These trial operators are going to countries like Brazil, China, Argentina and India. So, the clinical trials are moving towards other economies from the economies of developed countries.
What is your take on Indian pharma companies receiving US FDA warning letters?
US FDA’s main thrust is on the Quality By Design (QBD) and our main thrust is also on the same. So not just US FDA is quality conscious but we are too. So, wherever there is violation of norms we take actions. If you see the case of Johnson and Johnson where they flouted manufacturing process in a simple product like baby powder, we cancelled their license. So, we are as stringent as US FDA. We don’t differentiate between local companies and MNCs.
The fight between pharmacists and FDA was widely publicised. Are the rules very stringent or have pharmacists taken them lightly?
These rules are meant for the betterment of patients. Patients should get the services that are described in different acts. A lot of research goes into framing any act. Drugs are concentrated chemicals and cannot be sold like chocolates. Rules are there and I am just implementing them. This is how I work during my every posting. I have stressed on the presence of pharmacist in the shop, sale of medicines only with bill and no sale of prescription drugs without doctor’s prescription. All these factors are important from patient’s perspective. I found that about 34 per cent shops were operating without pharmacists. In the absence of a proper bill, counterfeit medicines would find easy access to the patient. Moreover, without bill it is difficult to recall the drug and also it cannot be determined whether drug price control order is being followed or not. Laws that were on holiday for many years, I am just implementing them. Pharmacists should comply with the law or go out of the business. Associations are not fighting with me, they are fighting with drug price control order. They are pressurising manufacturers to appoint a particular dealer or distributor, or else they threaten to boycott their products. These are backstage things which never come into the picture.