With the advantage of technology and scientific development, the spurious drugs have taken prominent role in day to day administration of drug laws as well as public health. While in common parlance, the spurious goods are understood to be fake drugs, but in a legal concept the spurious drugs has been dealt with differently. The spurious drug has been defined u/s 17B of Drugs and Cosmetics Act, 1940. It has dealt with the spurious drug in five manners as follow:
a) if the drug is manufactured under a name which belongs to another drug –
The proviso specifically stressed upon the name of the drug. The name includes proper name as well as trade name. For example if the product is Amoxycillin, but if is stated to be Cloxacillin, the latter will be taken as a spurious drug. Similarly if two products bear similar brand name it will amount to be a spurious drug. For example, brand name say CEFORM is of the manufacturer ABC and another company manufactures same brand CEFORM it can be considered as spurious drug. Similarly LIBROSAR and LIBROSAR, BOTOX and BOTOX, BIOCILIN and BICILLIN, SUPAXIN and SPOXIN are some examples of spurious drugs. It must be noted that this proviso includes trade name as well as generic name. The Hon’ble Allahabad High Court in Cattle Remedies Pvt. Ltd Vs. Cattles Cares Pvt. Ltd 2007 took the similar way and held that the name emphasized under the act includes both brand name as well as generic name.
b) if the drug is an imitation of or substitution for another drug or the name of such drug or packaging of such drug resembles another drug which is likely to deceive. –
The imitation of a brand name and packaging of another drug falls in such category. Resembling trade marks and copyright are the common place where by deception is created. Brand names like REFORM and REFORM, BOTOX and BOTOX, REGU-40 and REGULINE, CEFEX and CAFAX are some of the examples. Further it is seen that although brand names are similar or deceptively similar yet the formulations are different. Such drugs also fall in the category of spurious drugs. Sometimes there are cases of two parties using same generic brand name such as GLUCOSE-D .Under such circumstances the identity of the parties and drugs shall be clearly mentioned and there should not be imitation or confusion other wise even if generic name is used but since deception has been created the drug will fall in the category of spurious drugs.
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug , which individual or company is fictitious-
The provisions are very clear. If any drug is manufactured by showing name of the company which does not exist at all then such a drug is spurious. In many cases it is found that the manufacturer shown on the packaging does not exist at all. In many cases although the name of manufacturer is given but address given is false. This also leads to the conclusion that such a company is not in existence and so the condition of this proviso is made out.
(d) substituted wholly or in part-
There are occasions when the drug is substituted by another drug or another substance. For example, the label claims 500 mg Amoxycillin and if it is found that there is only 300 mg Amoxycillin then the conclusion is that 200 mg is missing and is substituted by some other drug or substance. If seen from this angle then it can be stated that there is 300 mg of amoxicillin + 200 mg of something else. This is the other part which makes the drug spurious. The Andhra Pradesh High court in Vinta Prasad Reddy and Anr. Vs. The State of A.P. and Anr. 2003CriLJ2264 while dealing in such similar case held that the claim made by the manufacturer is 250 mg Amoxycillin whereas it is found after testing to contain only 103.80 mg. Amoxycillin. The remaining is being substituted by something else and for this reason the drug is spurious.
(e) Not a product of a manufacturer as claimed-
Under this provision the drugs which is manufactured by one manufacturer if is shown to be manufactured by another manufacturer the case will be made out. For example, the Drug under brand name TORT is manufactured by company XYZ, but it is shown as is manufactured by ABC Company, the provision of this section is attracted. In other terms where the product is shown to be manufactured by another company either under a trade name or generic name, but where it is found that such claim is false, then the offence under this provision is committed.
DISCUSSION LIMITED TO IMITATION (trade mark issue)
The concept of spurious drug has wide amplitude and should not be taken lightly by the manufacturers. The provisions of section 17B more or less revolved around the brand name/name of the drug/trademark. The brand name is nothing but the trade marks as defined under the trademarks Act. What the law require is that the name of the drug/ brand name (trade mark) should not be similar.
Some aspect can be taken care by the manufacturers. But they take these issues very lightly and start manufacturing without even going for Search to ascertain whether such brand name is used by some other companies. The Drug Authorities also do not seem to be concern with the grant of similar brand name or at sometimes even same brand names. These factors lead to many disputes that are well known to the trade. The Drug Controller has authority and duty to see while granting drug approval, they must exercise caution.
On this point various Hon’ble High Courts and even Hon’ble Supreme Court has taken a stand many times; brief of these are as follows:
- CADILA Vs. CADILA AIR2001SC1952 (Supreme Court)
The Supreme Court held that in view of section 17B the Drug controller should consider taking search reports from the Trademark Registry before granting license to manufacture the drug. This clearly shows that section 17B dealt with the trade name and that if Drug Authority takes the search report from the Trademark Registry, the strenuous efforts made by the successful company to protect the brand name and packaging as well as the drug in toto can be minimized and curtailed by the Drug Controller at very initial stage itself.
- Bio-Chem Pharmaceutical Industries Vs. Astron Pharmaceuticals 102(2003)DLT840. (Delhi H.C.)
Para 18.-This exercise appears to be essential from another point of view. If the drug is spurious and the offence is punishable to sell the spurious drugs, then the Drug Controllers in absence of information may not take appropriate steps for prosecution of the guilty and the person who adopt this kind of trade mark innocently do not suffer prosecution for criminal offence. Ignorance would again lead to unnecessary wastage of time, energy and money of the State and innocent accused who fail to make any search about similar trade mark and the graph of ever increasing social cost in the shape of time, energy and money of the public officers and the Courts would continue to rise causing loss to national exchequer.
- Cattle Remedies Pvt. Ltd Vs. Cattles Cares Pvt. Ltd 2007 (Allahabad H.C.)
Held that the drug controller does not deal with the brand name directly but indirectly section 17B is relevant section in this matter.
- Antox India (P) Ltd. Vs. State Drug Controller, Tamil Nadu and others MANU/TN/0067/1990. (Madras H.C.)
Held that (Para 8) it is undesirable for the drug controller to grant another license to manufacture the drug under the same name and further held that If there was a disqualification to obtain a license even at the initial stage, then the grant of such license in contravention of the provisions of the Act, would be bad and the competent authority should have power to cancel the license which was granted under mistake.
SOME PRACTICAL ASPECTS
That if the drug is declared to be spurious the liability of such offence directly will fall upon the manufacturer. The responsibility of such violation can not be passed to the marketing company on the basis of the agreement. statutory provisions can be side lined by saying that the manufacturer has obtain affidavit from the marketing company. It is the duty of the manufacturer to ensure that the brand name under which he is manufacturing is not similar. It should not be deceptively similar either. The spelling may be different but it produce the similar phonetics then also the drug will be spurious.
EXPECTATION FROM THE DRUG AUTHORITY
From above, in conclusion, it can be said that if Drug Authority start exercising their power u/s 17B of the Act, the problem of spurious drug can be prevented to a large extent. If the stringent licensing conditions related to the brand name , labels and quantity are administered, there is no reason why the menace of spurious drug cannot be controlled and the name of the country cannot be established in the world market. Instead of depending upon the court to take action, it will be always better if the crime is curbed at the preliminary stage, if no license is granted at the beginning there will not be any dispute in future.
The timely prevention of the grant of similar name by the drug control office is not only beneficial to the department but also for the manufacturer who can be saved from the court litigation.
WEB SITE FOR SEARCH OF NAME
The trade mark registry has now made the search on line absolutely free for the benefit of the public and the manufacturer can log on to www.ipindia.nic.in
NOTE OF CAUTION:
The stringent provisions are made applicable under the new law where imprisonment up to 7 years or the Life as the case may be is imposed upon the manufacturer.
Caution: The view expressed above is purely the opinion of the author based upon the citation and provisions of law. No reliance can be made on the above in any legal proceedings. Please refer to the entire text of Judgment before acting upon it.
© reserved with author. Contributed to “Medicare News”.
Article by: SUSHANT MAHAPATRA, Advocate, Solicitor and Consultant on Drug laws, Patent, Trademark, Copyright and Company cases, practicing before Delhi High Court And Supreme Court, can be reached by Email: firstname.lastname@example.org., Web: www.macecorpn.com