by G Pramod Kumar Jun 10, 2013 15:54 IST
In the unresisted and rapidly rising cacophony against the FDA-tainted Ranbaxy, what get drowned unfortunately are voices that are vital to the country's drug industry and people's health.
Ranbaxy in the eyes of FDA (Food and Drug Administration) is certainly at fault; otherwise it wouldn't have pleaded guilty and paid a $ 150 million penalty to settle civil claims under the False Claims Act and $350 million under related State laws.
But the FDA's problem was about the unacceptable quality of processes and not the quality of drugs. There hasn't been any word by the FDA on the quality of the drugs so far, and this is the message that is lost in the noise.
On Saturday, the Director General of Health Services (DGHS) of India reportedly said the same thing: that Ranbaxy hadn't followed a couple of steps prescribed by the FDA, but that didn't mean that the company's drugs were sub-standard.
Jagran quoted DGHS Jagdish Prasad: "There are misconceptions about Ranbaxy producing sub-standard drugs. There was something wrong with the manufacturing process, but the quality of the drugs was fine."
"In the production of the medicines, the company may have forgotten to follow one or two steps prescribed by the US FDA, but that does not mean that the drugs are sub-standard," he reportedly added.
On 23 May, the WHO had said more or less the same thing.
In a suo moto statement in the wake of the controversy and anxiety over the quality of drugs, the WHO said that Ranbaxy products in its list of Pre-qualified Medicinal Products were not of "unacceptable quality." Some drugs in the list came from the same facility that the FDA was not happy about.
Ranbaxy is one of the generic companies, along with CIPLA, that are pre-qualified by WHO in a list of medicines for HIV/AIDS, malaria, tuberculosis and reproductive health. The list is a "vital tool" used by international and national organisations for bulk-purchases. The GFATM (Global Fund Against AIDS, Tuberculosis and Malaria) uses the WHO's pre-qualified list for its global procurement.
The pre-qualification process evaluates the quality, safety and efficacy of the medicines as well as the processes and capacity of the suppliers. WHO says that it has no problems with the quality of the drugs by the company in its list.
The WHO statement also gives a hint as to what could have happened in the debacle that Ranbaxy landed itself in: "the tools for the detection of non-compliance are similar to those detect data-fraud." In other words, non-compliance of FDA norms, could be rightfully interpreted as data-fraud.
"In the case of data manipulation, the intent is to supply false information. But situations also occur in which submissions are not accurate because systems for ensuring that dossiers are kept up-to-date and/or manage change management are inadequate," says the WHO statement, adding, "but the root-cause of the non-compliance is different."
Ranbaxy is certainly culpable under the FDA rules because there was non-compliance and there was no other way out than to accept its mistake; but what subsequently happened were concerted efforts to magnify the "malpractice" in a way that not only the company, but the entire Indian drug industry looked suspect.
The Indian generic companies are the bugbear for Big Pharma, which produce both patented medicines as well as generics, because they have demolished their medical industrial complex of mega-profits and exploitation.
The Big Pharma fight the generics in multiple ways and the easiest of them is to malign them for "poor quality" because it is consistent with the stereotype of the developing world - dirty, poor, lax rules and so on. This had happened many times in the past.
Still, Indian drug companies, purely out of their dint of perseverance and human capital, had made it to the big generic markets including in the US and Europe. Even the FDA goes out of the way to campaign for generics, and are appreciative of Indian medicines because they save Americans billions of dollars.
Therefore, the present ban on Ranbaxy drugs by some hospital groups are either an over-reaction or a business strategy to ensure that their patients, including the lucrative overseas clients, are not dissuaded by any anxiety over the quality of drugs. In fact, the Indian drug industry should have taken a proactive step in dispelling this because the MNC lobbies are hard at work and the national media are simply following suit.
A careful reading of the WHO statement, as well as the articles in the western press, makes it amply clear that it's not Ranbaxy's quality that's the issue. It's India denying the ever-greening of patents by the Big Pharma (e.g. cancer drug Glivec); India granting compulsory licences for local manufacture of patented drugs (e.g. Nexavar by Natco pharma and the possible grant of license on Sorafenib for breast cancer) and India making it to their own turf in terms of generics (half of the Indian generics markets are abroad).
Indians are a pain - they flood the global markets with extremely low-priced drugs. Had it not been the technical expertise of countries such as India, Brazil, Thailand and China, the Big Pharma could have had the entire world to themselves.
Listing the steps it had taken following the FDA's first warning letter to Ranbaxy in 2008, WHO says that it had oragnised several inspections, along with regulators from countries (SRAs), at the company's manufacturing sites including the Paonta Sahib in India, where the FDA had noted "significant deviations from the US Current Good Manufacturing Practice (cGMP).
The inspection included "verification of source data, quality control, and investigation of computer systems and related data." The team did observe "some non-compliances," but Ranbaxy subsequently "submitted documentation describing corrective and preventive actions, which were assessed by the inspection team and found acceptable," WHO said.
However, "there was no evidence to warrant any further action by WHO-PQP (pre-qualification procedure), or indeed by those SRAs who participated in this inspection."
This is the story that we haven't heard because the cacophony was designed by the Big Pharma propagandists. Unfortunately, even the Swadeshi voices didn't care much.
The biggest learning, however, is that cutting corners, or laxity in processes can have disastrous consequences. Perhaps the rest of India should learn this from the pitiful situation that Ranbaxy is in, and pull its socks up. It's time that we also looked good.
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