WHEN US FDA MEETS INDIAN PHARMA COMPANIES...

By Ruma Dubey

 “Everyone has different standards about cleanliness. The Westerners have different standards, we have different standards.”

We all had fumed, raved and ranted over this comment of Lalit Bhanot, the Delhi Commonwealth Games’ spokesperson. It was a politically incorrect thing to have said but had it hit home and hurt because it was true and we were simply in denial?

This is the thought which comes to mind when we read this news today about Biocon also being pulled by the ‘villain’ of Indian pharma companies – the U.S. Food and Drug Administration (U.S. FDA). The stock was down today as its Bengaluru unit has received ten observations on Form 483 by the FDA. This ranges right from nonconformity to procedures and lack of trained and skilled employees. Along with Biocon, almost the entire pharma clan is down in the red – one of the primary reasons why the market is in the red today.

Two days ago, Wockhardt announced its numbers and the ongoing FDA alerts have kept the performance muted. The market is extremely worried with this development as it feels this is the way in which things started going wrong for Ranbaxy, wherein it initially got an import alert at one of its plant after which it snowballed into all its facilities.

We as Indians accept and use the very same drugs which the US FDA thinks is unfit. Does that mean that we Indians do have different and much lower standards like how Lalit Bhanot had stated?

The ‘horror’ of US FDA became a household name with Wockhardt. It was amongst the first to receive a warning letter from US FDA over its facility at Waluj in Maharashtra for not pharmaceutical ingredients from its facility in Toansa in Punjab, to prevent substandard quality products from reaching US consumers.  Also the memory of Ranbaxy remains right at the top of the mind is still very fresh. Then there was  US FDA banning imports to USA from Ranbaxy due to manufacturing violations. 

Almost every company that we know of, amongst those listed on the BSE, have at one time or the other come under the FDA scrutiny. Companies like Sun Pharma, Cadilla, Dr.Reddy’s, Glenmark Pharma and Lupin had to recall some of their key drugs from the US market. So over the past few months, Indian pharma companies have been facing increasing heat from the US FDA.

The question is why this sudden spike up in inspection? Conspiratory theorists say that this is because the US pharma lobby wants to now protect itself. Indian pharma companies have a 10% market share in US and are the second largest importers of drugs into USA. Thus to reduce this growing clout of the Indian companies and clip their wings, the US FDA has suddenly got vigilant. Conspiratory theories are always interesting and thought provoking but without real proof, by merely putting one and one together, we cannot conclude this being the reason.

Another reason being cited is that the US FDA now has established two local offices in India, one in Mumbai and one in Delhi. Thus with ground staff there, right in the country, the inspections have gone up. The US FDA has implemented Good Manufacturing Practices (GMPs) and that is also the reason why scrutinizes have gone up manifold. But this still means that standards are poor and Indian companies are not US FDA complaint; it is as simple as that.

What could be a more logical explanation is that Indian companies are simply not yet ready for GMP compliance and that being the norm now for US FDA, the mismatch is now happening with increased frequency. As per the GMPs, all instructions are clear, entire manufacturing process is completely defined in a step-by-step format, records are kept of every step taken, facilities are designed to minimize cross contamination and mix-ups and more importantly, all operators are trained. These are stringent but very good standards. BRIC nations are not participating in the GMP Guide for Active Pharma Ingredients. Most GMP companies in India are struggling to meet the compliance cost and companies needing GMP manufacturing in India need to monitor processes and products closely to ensure it is in compliance with US FDA.

In India, there are over 20,000 pharma companies and they do not have very stringent and complex certification procedures. Surely, you would have come across someone around you who does job work or contractual manufacturing of capsules or tablets or bottles for some bigger pharma company. Do you think their facility would be GMP or US FDA compliant? Thus when the tally of all processes and products is taken, discrepancies are bound to arise. Also remember, FDA conducts inspection of only those facilities which export drugs to USA.

The Indian equivalent of FDA in India is Central Drugs Standard Control Organisation (CDSCO). It is the CDSCO which gives approval for drugs to be marketed, patented or distributed. So this means the real problem is that there is a major mismatch between quality standards established by FDA and CDSCO. The basic premise of CDSCO is itself flawed. The motto of FDA is that quality needs to be built into the product and mere testing alone cannot be relied upon. That is why so much importance is given to processes, keeping records and training the staff and operators. In India, CDSCO does not have anything which defines standard quality. The Drug The Controller General of India (DCGI) tests commercial samples following complaints, known as an adverse events, from consumers.  The CDSCO publishes a list of products that are tested by the central laboratories, which are found to be “not of standard quality. There is the Schedule M clause in India which governs rejection of products that fail tests but there is nothing as crystal clear as the US FDA law which stipulates processes. Nothing like this exists in India.

Processes and standards matter. ISO series have more than proven that.  Records, documents, and final products have to be made transparent or else how will we ever know whether the product has gone through any rigorous checks for quality? The IT industry adheres to global standard processes and products. So why can’t the CDSCO make itself truly global?

The US FDA warnings are good as it will make (hopefully) the CDSCO sit up and take notice and read the writing on the wall – it needs to change! It also comes as a wakeup call to Indian pharma companies where like us Indians, sab kuch chalta hai. More importantly, we as Indians should become more vigilant and try and avoid drugs from companies which are not US FDA compliant. That is a bigger worry.