A notice dated March 30 from the Drug Controller General (India) asking for ‘science-based suggestions/ comments’ on the pros and cons of replacing animal-based gelatin capsules with cellulose-based capsules has pharma companies wary and capsule manufacturers in a panic.
The notice has asked for suggestions in six weeks, but there is no indication of the timeline post the mid-May deadline. However, given that the Bureau of Indian Standards (BIS) released guidelines for the production of cellulose-based capsule shells last year, some industry experts caution that the DCGI’s call for comments is the last stage in a consultative approach before a decision is taken.
India is not the only country to consider a ban on gelatin-based capsules. The BIS document released in January last year mentions that the cross linking of gelatin and drug incompatibilities as well as the strict regulations regarding the use of animal-derived gelatin requiring the absence of bovine spongiform encephalopathy (BSE), encouraged the search for gelatin replacements. Such replacements have been in use for certain powdered herbs and dietary supplements, where, as pointed out by the BIS paper, a modified naturally occurring polymer cellulose considered safe for human consumption, hydroxypropyl methyl cellulose (HPMC) more commonly known as hypromellose, seems to have become the replacement of choice.
With a sizeable vegetarian population in the country, the move to switch from animal-based to vegetarian/ cellulose-based capsule shells would obviously have many takers. But capsule manufacturers estimate that cellulose-based capsules might be more expensive than gelatin-based one, though this claim has not been backed by any numbers so far.
Also, the DCG(I)’s notice does not give any hints on to the scope of the switch (i.e. will all capsules have to be cellulose-based or will this be restricted to some medications?) Secondly, how much time will the industry be given to make this change? Lastly, will this change in the ingredients will need approval and if yes, does it have to be from the state and/ or central agencies.
Seen in the light of recent orders, like the slashes in drug prices and the ban on 344 FDC medicines, this switch to cellulose-based capsules could be just a matter of time. As with the first two, the government will not back down once it has taken a decision unless industry can come up with ‘science-based suggestions/ comments’ to either switch or not to switch.
The May 1-15, 2016 issue presents a wide range of perspectives on the ban on FDCs. (See story: FDC ban: Haste Makes Waste?. Pages 28-33) While there is acknowledgment from most industry experts that many irrational FDCs needed to be weeded out, there is also a consensus that we must not regret the rationale of FDCs. What is needed is cool headed reasoning on all sides, much before each takes a stance which is difficult to reverse.
The regulator is willing to clarify and make some small concessions, whenever presented with sound logical arguments. For instance, DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) gives one instance. After concerted efforts over nine months to do away with the retrospective pricing, the only tangible change conceded by the NPPA is to clarify in its office memo (OM) dated April 13, that ‘Recalling or re-labelling or re-stickering on the label of container or pack of released stocks in the market prior to date of notifications, is not mandatory, if manufacturers are submitting revised price list… and are able to ensure price compliance at the retailer level.’ (See story: http://bit.ly/1SGZFx6; Recalling stocks to re-label drugs with revised prices not mandatory: NPPA). While this interpretation will address the practical problems faced by pharma manufacturers with regards to procuring stickers and handling the logistics of recalling and re-labelling batches, it is clear that the pricing authority is not letting the manufacturers completely off the hook.
To what extent are they expected to go to ‘ensure price compliance at the retailer level?’ Most companies, at least the larger ones, will not want to take chances and prefer to go the re-labelling/
re-stickering route. Retail associations have already informed the NPPA that this is the option they prefer.
The April 13 OM from the NPPA also cites the Supreme Court’s decision in the GlaxosmithKline Pharmaceuticals case, wherein the SC has held that ‘A consumer approaching a chemist/ retailer can hardly be offered two prices for the very same product based only on the difference in batch numbers. Consumer must get the benefit of the notified price.’ In this game of passing the buck, the manufacturers stand to lose the most so they would prefer to play safe. A similar outcome could be in the offing on the gelatin versus cellulose-based capsule issue. In a toss up between health concerns regarding BSE and cost-competitiveness, which argument will prevail? Or is there a middle path?
Viveka Roychowdhury
Editor
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