Maharashtra FDA trains guns on overpriced drugs

The Maharashtra Food and Drug Administration (FDA) is planning to approach the apex drug pricing watchdog, the National Pharmaceutical Pricing Authority (NPPA), to act against a set of medicines that is being sold at exorbitant prices. In an interview, Maharashtra FDA commissioner Tukaram Mundhe tells ET's Vikas Dandekar that his team is in the process of examining the data before proceeding further. Edited excerpts:

What are the key issues of focus in the pharmaceutical sector?

We are looking at the pricing of medicines. There is MRP, and there are guidelines. But over time, we have seen representations from civil society and NGOs that drugs are exorbitantly priced. It becomes a bad, unethical or immoral trade practice if the product is costing ₹100 but is priced at ₹1,000. So, we are examining the data, and if we see issues, then we will take it to the pricing authority, the NPPA. Like in the cardiac stent cases, we will work on that. We have some data, and we will see some results on that also.


You have served notices on well-known restaurants for non-compliance with hygiene standards. What is fuelling this?

My philosophy is not just to do the job. I must perform the role that has been assigned to me. The role goes far beyond just a job. My role is to regulate and ensure that safe food and safe drugs are available, and whatever is produced in Maharashtra is safe and follows standards as per the norms.

What are the next big moves?

We are looking at a whole gamut of things. Next in line could be spices...edible oil is also an important part. Many don't know that alcoholic and non-alcoholic drinks are also under the FDA purview, starting from quality to packaging. We have a strategy for it; we have a vision, so it is a question of time. These sectors will be touched and acted upon.

You have stopped hospitals from forcing patients to buy medicines from in-house pharmacies. How has it been received?

Nobody can force patients to buy medicines from a particular pharmacy. They have the right to purchase from a legal registered pharmacy-inside or outside the hospitals. I issued an order that if the medicine is not allowed to be purchased out of the hospitals, there will be action, and we have acted against a few hospitals in Nagpur, Pune, Mumbai and Solapur. By and large, hospitals are now following the rules.

How are you planning to tighten up the drug manufacturing units?

Every manufacturing unit must be of WHO standards. All GMP (good manufacturing practice) norms must be followed. We are finding several NSQs (not of standard quality), and we have increased our audits and surveys. Many recalls are ordered. Going further, we will tighten the process of auditing manufacturing and have all the HACCP (hazard, analysis and critical control points). Packaging, branding, temperature controls and testing standards will be more stringent. We are ensuring that fresh SOPs are issued. In blood centres, operations will be seen closely. We will ensure there are no spurious medicines.

How do you want to create a culture of compliance?

We want to create a culture where compliance is the norm. Our fair action should be a deterrent, and it should be followed without any fear or favour. There is no discrimination. If the licensees, FBOs (food and beverage operators) or drug makers are abiding by the law, there is nothing to worry, but if they are not, there is no place for them to hide on the earth. We interacted with officers, associations of drug makers, also from food and milk suppliers. We told them we will not spare any stone unturned to make sure that the law is implemented in letter and spirit.Antimicrobial resistance is a big issue and we have seen antibiotics given without prescriptions. Pharmacists selling prescription drugs without prescriptions is not allowed. We will take due action. We have started to suspend licences. Citizens should understand that taking antibiotics for smallest reasons is not good. There may be a temporary cure, but it will start getting resistance to antibiotics. There needs to be awareness about this through multiple channels.

Is safe food, safe medicines, safe Maharashtra your goal?

It is a gigantic task. In the food sector, we have 1.2 million licence holders, and we have more than 150,000 licence holders in manufacturing, blood centres and pharmacies. We may not be able to reach every unit, but everyone can reach us. We will take exemplary actions, and there must be deterrence of the law. All stakeholders, food and beverage operators, drug makers, regulators and citizens will need to be vigilant about what they eat, what they purchase, and what they consume.