Drug Formulations: Banking on Brands

Reproduced from: http://www.indialegallive.com/health/drug-formulations-banking-on-brands-65964, published May 26, 2019

Retaining the brand name in a new formulation is misleading and harmful for patients and state drug controllers can crack down on companies which do so

Dr KK Aggarwal

The central government has ordered state drug controllers not to allow pharma companies to market drug formulations in which the composition has been tweaked while retaining the old brand name. With this in place, certain companies will not be allowed to retain the brand name in medicines that have undergone a change in raw material or active pharmaceutical ingredient.

Hopefully, this will not apply with retrospective effect as a new law ought to be prospective, not retrospective. Article 20 (1) protects individuals against ex post facto legislation and says that no person can be convicted for an offence that was committed before the enactment of the law. This immunity is only limited to criminal proceedings. However, it does not prohibit a civil liability retrospectively, i.e. with effect from a past date. So, a tax can be imposed retrospectively.

The Union health ministry on September 12, 2018, banned about 328 FDCs (fixed-dose combination drugs) after an expert panel was formed under the chairmanship of Dr Nilima Kshirsagar, professor of clinical pharmacology at GS Medical College, KEM Hospital, Mumbai. The panel had to review the safety, efficacy and therapeutic justification of these drugs and found them “irrational”. Citing safety issues and lack of therapeutic justification, it recommended the ban which includes pain­killers and anti-diabetic, respiratory and gastro-intestinal medicines.

Over 6,000 brand names were banned. Many companies which had created a known brand lost their market share overnight and had to create new brands with new preparations.

Take one example. Codeine-containing cough medicine was banned in India from March 14, 2016. Pfizer Ltd, the Indian subsidiary of US-based drug maker Pfizer Inc., discontinued the cough syrup Corex (codeine plus chlorpheniramine maleate) in its then form, changed the composition but decided to retain the brand name for its future respiratory products. The new formulation is now called Corex T (codeine plus triprolidine). It is being marketed for dry cough. Since February 1, 2018, all over-the-counter (non-prescription) codeine-containing medicines for pain relief, cough and colds can be bought by prescription only.

Retaining the brand name in a new formulation where an ingredient has been tweaked is misleading and harmful for patients. The issue had been discussed for years now and was deliberated in several drugs consultative committee meetings since 2008. The expert panel was of the view that medicines where the ingredient is tweaked by companies but the brand name retained is “not only misleading, but may result in undesirable pharmacological effects” as the consumer would take the formulation, assuming it was the earlier composition. This is especially so in India where even scheduled medicines can be bought without prescriptions.

Even Section 200 of the IPC (using as true such declaration knowing it to be false) and Section 415 (cheating, deceiving, fraudulently or dishonestly) may become applicable in such cases. The Supreme Court had held almost 18 years ago in Cadila Health Care Ltd vs Cadila Pharmaceuticals Ltd that there ought to be some coordination between the trademark registry and drug authorities. In this case, the Court had observed that “drugs are poisons, not sweets”.

Under the Drugs and Cosmetics Act, 1940, the Drug Controller General of India (DCGI) and state FDAs are vested with powers to supervise and overlook the manufacture and sale of drugs. Sections 17 and 17A of the DC Act deal with misbranded and adulterated drugs. Central and state governments are empo­wered to appoint inspectors who have vast powers as stipulated under Section 22.

The High Court of Delhi in the matter of M/s Curewell Drugs & Pharmaceuticals Pvt Ltd & Anr vs Ridley Sciences Pvt Ltd had issued an order on August 14, 2018, that the DCGI and state FDAs ought to implement an action plan in which drugs with identical or near identical brand names or marks are not given licences so as to ensure that no confusion is created among doctors, chemists and patients. Though the context in this case was different, the spirit of the judgment was not to create any confusion in the minds of people when it comes to brands.

The Supreme Court in the Cadila Health Care case had said: “Keeping in view the provisions of Section 17-B of the Drugs and Cosmetics Act, 1940, which inter alia indicates that an imitation or resemblance of another drug… likely to deceive being regarded as a spurious drug it is but proper that before granting permission to manufacture a drug under a brand name the authority under that Act is satisfied that there will be no confusion or deception in the market. The authorities should consider requiring such an applicant to submit an official search report from the Trade Mark Office pertaining to the trade mark in question which will enable the Drug Authority to arrive at a correct conclusion.”

Subsequently, in compliance with the order of the Delhi High Court, a meeting was held under the chairmanship of additional secretary and Director General (Central Government Health Scheme), Ministry of Health and Family Welfare, on November 13, 2018. At the meeting, it was discussed that the brand name/trade name in the case of pharmaceuticals is neither controlled by the licensing authority under the Drugs and Cosmetic Act nor the trademarks office at present. This allows scope for having the same trade names for different drugs manufactured and sold. Thus, the Drugs and Cosmetic Rules, 1945, may be amended to include provisions for regulating brand names/trade names by central and state licensing authorities.

The Drugs Technical Advisory Board after detailed deliberation recommended devising a mechanism under the Drugs and Cosmetics Rules, 1945, to include provisions for regulating the brand names/trade names of pharmaceutical products. With no system in India for the DCGI to inform every doctor about this, confusion is sure to persist.

As for companies, they prefer using popular brand names for new products containing different ingredients as it is easier to market them. Also, they would have spent a lot of money in building that brand name.

As long as the name is for the same indication and the company ensures safety by making a rational combination, it can justify it. Of course, extensive communication and information to every healthcare provider should be given.

Similarly, a name change of a drug under these circumstances should be communicated on a one-to-one basis to every doctor and not by an advertisement. This seems a difficult task as even the MCI does not have the records of all practising doctors in India.

All possible efforts should be made to avoid mistakes with brand names. Prescription errors are the number one cause of medical errors in the country.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA