As part of my research on the Indian pharmaceutical market, I’ve been trying to interview a full mix of stakeholders: companies, physicians, hospital administrators, pharmacists, patients, etc. However, I was especially looking forward to speaking with government regulators, and last week I was able to do just that, spending two days at the offices of the Food and Drugs Control Administration (FDCA) of the state of Gujarat.
Different states in India have come with different solutions to manage pharmaceutical quality. Tamil Nadu, for instance, has just released a set of ‘Amma’ pharmacies, managed by the state. The state procures high-quality medicine and saves money by cutting out a lot of the middlemen so they can offer the drugs 10% off maximum retail price. Gujarat on the other hand has come up with a sophisticated IT system where they can communicate quality information with pharmacists using SMS messages. I had been looking forward to hearing about this system and learning both how it was developed and how it has been working.
As I have commonly found in India, the Gujarat FDCA could not have been more hospitable or welcoming. I arrived in Ahmedabad and was greeted immediately by two senior drug inspectors, before heading to the head office, where I was warmly greeted by the FDCA Commissioner, Dr. H.G. Koshia, the Joint Commissioner, Mrs. D.R. Chauhan, and many others.
Gujarat is an important state for pharmaceuticals. The pharmaceutical industry has been active in the state for over 100 years; they are the second-largest state in number of pharma units (after Maharashtra), manufacture 28% of India’s pharma exports, and house 40% of India’s Contract Research Organizations. In addition to pharma, they are also a hub for production of medical devices, such as IV sets, orthopedic implants, cardiac stents, etc. The Gujarat FDCA employs over 1,300 people and is responsible for testing not only drugs, but also food and cosmetics. Their vision is “To safe guard public health” and this was the number one thing I heard consistently from everyone. Their head office is in housed in Gandhinagar, with their Drugs Testing Lab about 90 minutes away in Vadodara. My second day in Gujarat, I was able to tour the Drugs Testing Lab, which is actually comprised of multiple labs throughout multiple buildings. On the day of my tour, they were doing training for new liquid chromatography equipment that had arrived that day, but unfortunately I forgot to take any photos! However, the general system for drug testing is as follows: there are 25 district offices. Each office must collect a minimum of 6 drug samples per month, which means there is a minimum of 1,800 samples per year (though the actual number has been much higher). These samples have to be collected from different points in the distribution channel – directly from the manufacturer and from hospitals, wholesalers and pharmacists. This is essential because certain products must be stored at a certain temperature to ensure quality. If a manufacturer produces a drug correctly but a wholesaler is storing it at a high temperature, then the product will fail quality tests due to no fault of the manufacturer. These samples are then entered into the IT system and sealed with wax using unique seals so that they cannot be tampered with, then sent to the Drugs Testing Lab in Vadodara for testing.
From the drugs testing lab, the drug quality is tested (for dissolution time, active ingredients, etc) and results are again entered in the IT system. If a drug is found to be not of standard quality (NSQ) for any reason, it is checked by the administration and then a SMS text-message alert goes out to every pharmacist in Gujarat, giving the name of the drug, manufacturer and batch number so that they will immediately pull the product from their shelf. Further, this information is made available to the public online so that they can track their medication. This SMS system is possible because the IT system also contains registration information for each pharmacist and manufacturer in Gujarat. With the IT system, the government is able to test many more drugs in the same period of time and disseminate results to the public immediately and completely. The success of this system has been largely due to the connection of all aspects of pharma – manufacturers, pharmacists, and drug testing, into one combined system. In fact, now 12 Indian states have adopted Gujarat’s IT model.
As a contrast to this system, prior to the implementation of this IT system, NSQ results would reach the Commissioner only after a series of signatures from other employees. Then the Commissioner would sign the results, and give them to an officer or administrator who would inform the manufacturer. The manufacturer would have no incentive to rush in pulling their product off the shelf, and there was always the chance they would try to bribe someone in the office. By the time a product was pulled off the shelves, up to 100 days could have gone by. Results of NSQ drugs were distributed to the public via news media, but that made it hard to reach everyone. In addition, those with a pharmacy degree were not being tracked themselves, so would often work or register at multiple pharmacies, so you could not guarantee a trained pharmacist at any given pharmacy at all times. Now, since pharmacists must register on the IT system, they can only be registered to one pharmacy and this ensures that the government has their updated mobile number, meaning the NSQ SMS alerts will reach every pharmacist in the state. Further, as expected, the registration process for pharma manufacturers has become much quicker with the IT system. And lastly, the IT system is used to compare and rank the 25 district offices based on a scoring system. Since no one likes to come in last (it’s human nature!), having this ranking has improved the results of every single district office. In fact, the initial “high score” ranking is now lower than the current lowest score.