What’s in a name?

Pharma companies take advantage of legal loopholes to market different formulations under same or similar brand names, says Sapna Dogra

Markets in India are flooded with too many medicines that are being sold under similar or identical brand names, putting patients at risk. Imagine a scenario where a patient is prescribed Lona, a brand of anti-epilepsy drug clonazepam marketed by Triton Healthcare Private Limited, Chennai, but is sold Lona marketed by Dabur, containing low sodium salt and meant for hypertensives! There are hundreds of other examples wherein patients are being exposed to health hazards due to similar brands containing different ingredients.

Milking brand loyalty

For instance A to Z contains multi-vitamins, A-Z has cetirizine while AZ brand is used by at least three different manufacturers for entirely different medicines i.e. azithromycin, albendazole and cetirizine. These startling findings were made in a study by Monthly Index of Medical Specialties (MIMS). Pharmaceutical companies are indulging in such practices for profit according to Dr CM Gulati, Editor, MIMS. “Pharmaceutical manufacturers continue to use old, established brand names even after changing the ingredients because they don’t want to lose brand loyalty,” he explains.

Dr PC Bhatnagar, Director, Community Health Division, Voluntary Health Association of India (VHAI) agrees and says, “Usually when certain formulations/compositions become obsolete or are banned, companies retain the original name of the medicine because of its recall value. The problem occurs when the doctors are not informed properly or when people buy OTC drugs.”

Same name, different recipe

The MIMS cites more examples of this trend. For instance, piroxicam in Movon, marketed by Ipca, has been replaced with aceclofenac. The use and safety profile (dose, contraindications, special precautions, drug interactions and adverse drug reactions) of piroxicam are different from those of aceclofenac. For example the new Movon is contraindicated in pregnancy while old Movon was not. The same company is also selling aceclofenac under another brand name Zerodol. Similarly, in Incidal the short-acting mebhydrolin has been replaced with long-acting cetirizine. The dosage schedule of old Incidal was one tablet 3 to 4 times daily while new Incid’l is to be taken only once daily. Since patients are not aware of the change of formula, they continue to consume Incid’l 3-4 times daily! Overdose of Incid’l leads to potentially serious side effects.

There is a long list of medicines where established brands are being used for new ingredients such as Suganril (oxyphenbutazone replaced with piroxicam), Zimalgin (analgin replaced with caffeine), Actimol (phenylbutazone replaced with diclofenac) and Zil (tinidazole replaced with ornidazole).

Sound-alike, not do-alike

Another common problem that the MIMS study noted was that even when brand names are not identical, many are deceptively similar. For example Sivoxol is a combination of salbutamol, theophylline and ambroxol while Sivozol contains ofloxacin and tinidazole; Tocan contains clindamycin while Tocon is a brand of ketoconazole. A quick glance at just 300 manufacturers finds that there are more than 20 similar brand names all starting with just one alphabet A, such as Adiflox/Adilox, Adlin/Adliv, Alzol/Alzot etc. This is because there is a shortage of distinct brand names with over 17,000 pharmaceutical producers manufacturing more than 40,000 brands of just 450 or so basic molecules. Moreover, producers are keen to use short, easily remembered brand names that give some indication of the ingredient. Alzol was so named because “Al” and “zol” can be identified with albendazole while Alzot is supposed to remind the prescriber of alprazolam.

No brand name regulator

Experts feel that this situation is the result of the lack of laws in the country to determine the use and registration of brand names. “Neither the Drugs Controller General, India (DCGI) nor the state-level Food and Drug Administration is required to keep an updated record of brand names used by various companies,” says Dr Gulati. DCGI is charged with the task of approving new medicines under their generic names whereas state Food and Drug Administrations issue manufacturing licences. According to Dr Akhil Sangal, CEO Indian Confederation for Healthcare Accreditation,says though doctors are informed about the changes, the information is not widely publicised, which creates confusion. This can be gauged from the fact that most doctors think Lona contains low sodium salt and are not aware that there’s an anti-epilepsy drug clonazepam by the same name!

Like other consumer items (telephones, cars, and air-conditioners), brand names of medicines can be registered with the Trade Mark Registry. However, it is not compulsory to register trade names of any item in the country, including drugs. The result is that if brand name AZ is not registered with the Trade Mark Registry, any number of manufacturers can use it for any number of products. Even when a brand name is registered, it is applicable to one particular class of items. The result: the trade name Lona, even if registered by one company for low sodium salt can be used by another manufacturer for clonazepam since these two items fall under different classes of products. Dr Mira Shiva of VHAI insists, “The government has to bring regulation to put a stop to this malpractice, which jeopardises the patients’ health for commercial benefits.”

Loopholes in pricing law

Yet another point highlighted by the MIMS report is pharma companies taking advantage of the loopholes in laws governing drug prices. As per current policy, prices of some but not all drugs are controlled by the government. For example, among decongestants, the price of pseudoephedrine is controlled but the other two agents in the same category, phenylephrine and phenylpropanolamine can be sold at any price. So a company launches a product under a brand name such as Cetrizet-D that contains cetirizine and pseudoephedrine. As per government rules, its maximum retail price is fixed at Rs 8.11 for a strip of 10 tablets. “Once the brand gets established, the price-controlled ingredient pseudoephedrine is quietly replaced with phenylephrine and the price jacked up by 350 percent to Rs 28.20,” reveals Dr Gulati.

No company should be allowed to use the same brand name for two different medicines. In India, this issue was settled several years ago when Disprin Plus containing paracetamol was launched while Disprin contains aspirin. Under the threat of a ban, the company had to withdraw the brand. Dr Gulati wants to know why the same principle is not being applied in the case of Cetrizet-D.

India needs a central authority to monitor the registration of trade names since one state-level authority cannot have jurisdiction over another state, explains Dr Gulati and laments that currently there’s no central or state law specific to the use or registration of brand names of medicines.

The situation urgently calls for a single central drug regulatory authority which has the responsibility to approve, register and publish drug brand names and formulations, applicable across state lines.

— sapna@expresspharmapulse.com