Gujarat Drug Regulator Sets the Bar High

How did you feel when you read in the newspaper that two drug majors Ranbaxy and Wockhardt were pulled up by US regulators for impropriety in manufacturing practices and submitting false data about their products? Were you worried about the quality of medicines that you bought at the neighborhood pharmacy? Would you feel confident that the medicines your doctor prescribed to your child were of the best quality? Who can help you to answer these questions?

COMPLEXITY AND INADEQUACIES

India’s Drug Regulator or the Central Drug Standards Control Organization or CDSCO is charged with exactly that duty. It must lay the concerns of the Indian citizen to rest and ensure that the medicines available in the country are of the best quality, are affordable and are readily available.

Sadly, that is not always the case. A 2012 report from an Indian Parliamentary Committee exposed many failings such as inadequate infrastructure, shortage of drug inspectors and a lack of accurate data. In 2003, the R.A. Mashelkar Committee report estimated a requirement of more than 3,200 drug inspectors. Currently there are 1364 sanctioned posts, and around 864 are filled up. 

The Drug Controller General of India (DCGI) recently told media that Rs 3,500 crore would be spent on expanding the regulatory agencies by 2017. The result of the lapse is that 3% to 20% of medicines made in India are spurious, depending on what data you look at. Your fear for the quality of medicine you buy for your child is not totally unfounded.

India has a complicated regulatory structure and a web of entities at the central and state levels tasked with monitoring the pharmaceutical industry. This complexity causes much to fall between the cracks. This becomes evident when the industry declares over 20,000 licensed manufacturing units and the DCGI estimates them at only 8000.

CREATIVITY IN GUJARAT

State governments are responsible for licensing, approvals, inspection and recalls of drugs manufactured in their jurisdiction. With the aforementioned challenges, the Food and Drug Administration in Gujarat stands out for its creative use of IT based services to ease up the entire pharmaceutical value chain – from manufacturing to dispensing medicines to patients.

With over 3000 manufacturing units, Gujarat accounts for nearly a third of India’s pharmaceutical manufacturers and about 28% of exports. To cut out inefficiencies such as travel time, paperwork and physical presence at drug regulator offices, the State Food and Drug Administration (FDA) digitized and crunched the process. Manufacturing licenses for new plants are issued in 15-20 days (inclusive of site inspection) which is far lesser than the mandated 30 days. The resultant cutting of red-tape has attracted companies based in neighboring Maharashtra to set up manufacturing bases in Gujarat.

SPEED ACROSS THE VALUE CHAIN

To improve the distribution of medicines across the state, 1300 officers across 25 district offices are empowered to issue retail pharmacy licenses online. In most cases when the application is genuine, the licenses are issued the same day. Technology has helped connect the entire state machinery and curtail malpractices like multiple licenses issued to the same pharmacist which was possible in the days of offline license allocations when district offices were not connected and one district officer had no way of checking if the applying pharmacist already had another license issued in a different district. As a result, avarice and corruption has been controlled to a great extent.

THE PATIENT BENEFITS

When a fake medicine is discovered or a medicine fails the quality test, the State FDA sends out the information through an SMS to the 30,000 retail pharmacies across the state almost. Patients benefit through the use of technology as they have easy access to information about failed, spurious and unapproved medicines on the FDA website A patient who earlier had no way of knowing about fake medicines feels tremendously empowered when he has the same information as the seller. The process is so popular that it has been adopted by other states like Maharashtra and Kerala amongst others.

While the use of technology is not a substitute for manpower (inspectors are still needed for physical inspection of manufacturing plants and retail pharmacies) it definitely speeds up the entire process and makes it easy for the manufacturer and the consumer alike. Wouldn’t you feel relieved when you know that your neighborhood pharmacy sells the best medicines that you can confidently buy for your child?

Published on 21/11/13 at Mera Bharosa here

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