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
