Are We Aligning or Aping?
The Drug Controller General of India (DCGI) has stated that manufacturing licenses will only be issued based on generic or chemical names, and not on brand names. Archana Shukla recently reported that industry is divided on whether this is fan indicator of the government’s move to push generics eventually banning the brand names for drugs.
The matter seems to have been clarified with the DCGI at least for the time being as stated by the Indian Pharmaceutical Alliance’s secretary general, DG Shah. The main aim of this circular is to align ourselves to international standards and separate manufacturing licenses from trademarks. It is a step to deal with the similar-branding issues, as many brand names sound similar for a number of drugs currently on the market. It is not to eliminate brand names.
While this ends the ban-on-brand-names-for-drugs speculation a number of questions and concerns remain. The government has ordered the public sector doctors to prescribe only generic names and not brands. In a country where over 90 per cent of the drugs consumed are branded generics how can the move from branded generics to generic-generics possible. Not only that, most of the countries pharmacies are staffed by unqualified personnel. How will they dispense chemical names and contend with difficulties of this change? Furthermore, more than 50 per cent of the drugs currently used are combination drugs. How will the doctors prescribe a combination drug as a generic?
There is more to international standards than merely changing over to generic prescriptions. The entire eco system of the highly regulated markets is different. In the US, which is the biggest market for generics there are innovator drugs or brand-name drugs, branded-generics and generic-generics. The prices of brand-name drugs are out of price control as the drug discovery costs and risks are very high and the drug companies have to recover the investments before their patents expire. The first-to-file and first-to-enter the market generic drugs too have a window of 180-days of exclusivity during which period the prices are much higher than the generic-generics. The prices of generic-generics of course would be much lower.
The next question concerns the quality of the generics. There are not so many generic variations after the patent expiry. There are very stringent quality control measures to ensure that the generics are effective in treating the patients. Every generic drug should submit a bio-equivalence test comparing it with the innovator drug as they believe that therapeutic equivalence is important and chemical equivalence does not necessarily mean that it is therapeutically equivalent. Moreover, the generic applicant should conduct this test at the US FDA approved laboratory only. All this costs a lot and puts an entry barrier for fly-by-night operators.
Contrast this with the current scenario in the Indian drug regulatory environment. The technical infrastructure is not comparable and is not ready to ensure all these quality issues. Many of the reported close-to-ten-thousand drug companies do not have a manufacturing facility that conforms to and approved by WHO GMP (World Health Organization’s Good Manufacturing Practices). Under the loan licensing system literally anyone with less than a million rupees can start a company marketing his own version of generics. As a result, there are companies competing at international level, national level, regional level and even local level as there are no barriers to entry. No safeguard to quality.
Yes, it is a level playing field where products with assured quality and not-so-good at quality can survive and have equal opportunities to co-exist! In such a hyper-proliferative market, without adequate infrastructure for testing and checking quality, how will the DCGI ensure that the patients get the same quality of generic-generic that is identical to that of the brand-name drug? A brand-name manufacturer has got his entire reputation at stake. What does a generic-generic manufacturer, who is new to the business has got?
All this makes one think and ask “are we aligning ourselves to international standards or simply aping them?”