The Union health ministry recently set up an expert committee that will hear various stakeholders to ascertain whether animal-origin gelatin capsules should be replaced with plant-origin cellulose capsules. This move has caused alarm among Indian drug manufacturers. The backdrop for the proposed shift is rooted roots in the fact that a large section of the Indian population is vegetarian. However, the proposal is worrisome as it is, so far, devoid of any scientific rationale—there is no analysis showing cellulose capsules are safer than gelatin ones. Globally, gelatin capsules have been time-tested and are held to be safe and are recognised by regulatory agencies across the globe, including the US and the EU. That over 95% of all capsules in world are gelatin ones is strong evidence supporting these. Gelatin capsules have been used for more than 185 years now. Pharmaceutical companies with presence in markets across the globe have their compounds delivered in gelatin capsules, backed by scientific and technical analysis. As compared to gelatin capsules, the number of cellulose capsules that have been approved is significantly less. At this juncture, it becomes important to trace the back-ground of all the health ministry’s proposal. In March 2016, the Central Drugs Standards Control Organization (CDSCO) had issued a public notice seeking opinion on the replacement of gelatin capsules with cellulose capsules.
You May Also Like To Watch:
The CDSCO received various representations from industry participants, and it was decided that there was no justification in switching from the time-tested gelatin capsule formulation to cellulose capsules. The Union health minister has also stated in Rajya Sabha that there is no evidence available to suggest that cellulose capsules were safer than gelatin capsules. There have also been several proposals made to the Drugs Technical Advisory Board (DTAB) to label cellulose capsules with the ‘green dot’ to indicate their vegetarian origin—drawing a distinction from the ‘non-vegetarian’ gelatin capsules. The DTAB shot down the proposal and stated that drugs are not taken by choice and are prescribed by doctors to save lives, and therefore marking them of being vegetarian or non-vegetarian origin is not desirable.
As its recent move shows, the health ministry hasn’t backed out of trying to force cellulose capsules down patients’ throats. At this stage, even though comments from public have been invited, what is of particular concern is the health ministry’s insistence on getting its way through on a matter that was addressed by the industry at large during the year 2016. Alternatively, it would be very useful if the health ministry undertakes an extensive study on scientific and technical lines and prepare a road map for an eventual introduction of cellulose capsules over the course of the next 10-15 years.
While the recent beef ban and the associated cow vigilantism caused the country to attract negative limelight in global media, the new proposal, of forcing vegetarian capsules on the public, seems to suggest that there is indeed no method to the madness in what is being proposed by the Union health ministry, especially when the matter is about medicines and life of patients.
With India being one of the fastest-growing economies of the world, the government needs to clearly rethink its recent moves and adopt a careful stance so that it does not cause any abrupt shocks to the health care industry. After 1991, the Indian pharmaceutical industry’s has been a success story with several Indian companies becoming global players. Many global pharmaceutical majors have also made investments and set up units in India. Any move by the government that breathes carelessness could have major ramification on this bright spot of Indian industry.
–With contributions CV Srikant, associate at J Sagar Asscociates, Advocates and Solicitors