Pharmaceutical companies in the country are increasingly resorting to change in the composition of their fast moving products with no change in the brand names to escape the ban of irrational combinations and the provisions of the DPCO. Usually such composition changes are done without informing the state licensing authorities.
Physicians and patients are unaware of such critical changes in the active ingredients effected by the companies. As there has been no action by the state drug authorities against such companies, the number of such misbranded products is on the rise in the market.
According to informed sources, at least 100 such brands of drugs are floating in the market. The pharma companies, indulging in this unfair practice, spend crores of rupees to get their brands established and are, therefore, reluctant to give up their brand names. The state drug control authorities and DCGI’s office are aware of this practice but have not initiated any concerted action to check this unethical practice which directly affects the consumers.
A recent case is that of Cetrizet-D, a cough cold preparation containing cetrizine and pseudoephedrine marketed Sun Pharma. Soon after the price for Cetrizet-D is fixed at Rs.8.11 for strip of 10 tablets, the company changes composition by replacing pseudoepedrine with phenylephrine and the price is jacked upto Rs.28.20.
In the case of Ultragin of Wyeth, the combination containing Analgin and paracetamol was approved by authorities and established as a successful product in the market. But after DCGI declared the product as a irrational combination and the company quietly removed Analgin from the combination and started marketing with only paracetamol but retaining the same brand name.
Another case is that of Aspirin preparations of Rekkit Bencksier’s namely Disprin and Nicholas Piramal’s Aspro, two well-known brands. In 2001 both Reckit and Nicholas replaced the main ingredient Aspirin with paracetamol after NPPA cut the price of aspirin but continued to the same brand names by adding suffix ‘Plus’. In both the cases companies were charging higher prices for their paracetamol products.
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In the case of Reckitt, the Karnataka drug control authorities objected to the company’s keeping the brand name Disprin Plus as it contained only paracetamol. Reckitt then changed the brand name to ‘Disprin Paracetamol’ and continued marketing for some more time. Now both the companies have switched over to their original brand names namely Disprin and Aspro with aspirin.
The case of Sarabhai’s Phosfomin, a general tonic, is more interesting. As its name suggests, it earlier contained a combination of phosphates and minerals, with calcium and sodium glycophosphate, as main ingredients. Now Phosfomin contains neither phosphates nor minerals, and is a B complex deficiency drug. The company changed its active ingredients from time to time. As per the MIMS India issue dated January 2004, the drug had Vit-B-1, B-2, B-6, B-12, Niacinamide 13 mg, d-panthenol 2.5 mg, etc as ingredients, and a 250 ml bottle was priced only Rs 32. The same Phosfomin, as per the May 2005 issue of MIMS, does not contain Niacinamide 13 mg and d-panthenol, and instead has new ingredients namely yeast extract of 175 mg and l-lysine hcl of 100 mg. The drug is indicated for same B-complex deficiency, and is priced higher at Rs 44.28 for a 240 ml bottle.
A few other cases are: Incid'l of Bayer contains cetirizine while earlier Incidal contained mebhydrolin. Zil of Nicholas Piramal had tinidazole, now it has ornidazole. Esgipyrin of Sarabhai Piramal now contains diclofenac + paracetamol while earlier it contained phenylbutazone + propyphenazone. Movon of Ipca contains aceclofenac while earlier it contained piroxicam.