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Here is one doctor that people need to be wary of. Taking advantage of the swine flu hysteria, this doctor from Lonand in Satara district promoted a general influenza vaccine as H1N1 vaccine.
FDA raid
The deceit of Dr R R Gandhi was exposed after the FDA (Food and Drug Administration) of Pune and Satara circle jointly conducted a raid last week under the Drug & Magic Remedies (Objectionable advertisements) Act, 1954.
In this raid, the officials seized 79 pre-filled syringes of Inactivated Influenza vaccine IP that were manufactured by a Chinese company and marketed in India by Lupin Pharmaceuticals.
R B Joshi, assistant commissioner, Pune FDA, said, ?Dr R R Gandhi from Lonand promoted Inactivated Influenza vaccine IP, which is actually meant for general influenza, as H1N1 vaccine.
He even advertised this vaccine as swine flu vaccine on local cable network and said its price is Rs 600. After we got information about this advertisement, we conducted a raid and seized 79 pre-filled syringe from him. We have prohibited him from using this vaccine without FDA permission.?
FDA notices
A K Jagtap, assistant commissioner of Satara FDA, that played a major role in this raid, said, ?FDA has sent a notice seeking clarification from Lupin Pharmaceuticals which was marketing this vaccine in India.
We have asked in the notice whether the company had issued any guidelines to the marketing team about the use and promotion of Inactivated Influenza vaccine IP and also about import licence, product permission and distribution record of the vaccine.
A medical representative (MR) of Lupin Pharmaceuticals of Lonand taluka said he had nothing to do with the advertisement in question. We are waiting for a clarification from Lupin.?
Mirror has in its possession notices sent by FDA to Dr Gandhi, Lupin Pharmaceuticals and the cable operators Jagtap added, ?FDA has clamped down on the broadcast of the advertisement and sent a notice to the cable network owner under the Drug & Magic Remedies (Objectionable Advertisement) Act, 1954.
Though the vaccine is authorised by WHO and manufactured in China, doctors cannot take advantage of public fear by promoting it as a vaccine for H1N1.
Medical professionals should be aware of the fact that H1N1 vaccine is still in the research stage in India. So, a doctor cannot promote general influenza vaccine as H1N1 vaccine.?
On being asked about the action taken against Dr Gandhi, Jagtap said, ?Gandhi admitted to his mistake and apologised in writing.
He also discontinued the advertisement of the advertisement immediately. So, we allowed him to continue to practice.?
Misleading ads can be dangerous: IMA
Dr Dilip Sarda, president of IMA (Indian Medical Association), city chapter, said, ?Doctors should not mislead the patients about usage of influenza vaccine.
Before suggesting or promoting any influenza vaccine, he or she should collect information about the usage of vaccine.
How can a doctor promote a vaccine as H1N1 vaccine when it is clear that H1N1 vaccine is not available in India as yet??
Sarda added, ?When doctors mislead patients into believing that they have been administered the swine flu vaccine, they tend to be careless so far has hygiene and preventive measures are concerned. If anything happens to them, who is to be held responsible??
What the law says
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 stipulates: No person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which
?in the case of a first conviction, with imprisonment which may extend to six months, or with fine, or with both;
?in the case of a subsequent conviction, with imprisonment which may extend to one year, or with fine, or with both
Penalty
Whoever contravenes any of the provisions of this Act [or the rules made there under] shall, on conviction, be punishable:
?directly or indirectly gives a false impression regarding the true character of the drug; or
?makes a false claim for the drug; or
?is otherwise false or misleading in any material particular
FDA raid
The deceit of Dr R R Gandhi was exposed after the FDA (Food and Drug Administration) of Pune and Satara circle jointly conducted a raid last week under the Drug & Magic Remedies (Objectionable advertisements) Act, 1954.
In this raid, the officials seized 79 pre-filled syringes of Inactivated Influenza vaccine IP that were manufactured by a Chinese company and marketed in India by Lupin Pharmaceuticals.
R B Joshi, assistant commissioner, Pune FDA, said, ?Dr R R Gandhi from Lonand promoted Inactivated Influenza vaccine IP, which is actually meant for general influenza, as H1N1 vaccine.
He even advertised this vaccine as swine flu vaccine on local cable network and said its price is Rs 600. After we got information about this advertisement, we conducted a raid and seized 79 pre-filled syringe from him. We have prohibited him from using this vaccine without FDA permission.?
FDA notices
A K Jagtap, assistant commissioner of Satara FDA, that played a major role in this raid, said, ?FDA has sent a notice seeking clarification from Lupin Pharmaceuticals which was marketing this vaccine in India.
We have asked in the notice whether the company had issued any guidelines to the marketing team about the use and promotion of Inactivated Influenza vaccine IP and also about import licence, product permission and distribution record of the vaccine.
A medical representative (MR) of Lupin Pharmaceuticals of Lonand taluka said he had nothing to do with the advertisement in question. We are waiting for a clarification from Lupin.?
Mirror has in its possession notices sent by FDA to Dr Gandhi, Lupin Pharmaceuticals and the cable operators Jagtap added, ?FDA has clamped down on the broadcast of the advertisement and sent a notice to the cable network owner under the Drug & Magic Remedies (Objectionable Advertisement) Act, 1954.
Though the vaccine is authorised by WHO and manufactured in China, doctors cannot take advantage of public fear by promoting it as a vaccine for H1N1.
Medical professionals should be aware of the fact that H1N1 vaccine is still in the research stage in India. So, a doctor cannot promote general influenza vaccine as H1N1 vaccine.?
On being asked about the action taken against Dr Gandhi, Jagtap said, ?Gandhi admitted to his mistake and apologised in writing.
He also discontinued the advertisement of the advertisement immediately. So, we allowed him to continue to practice.?
Misleading ads can be dangerous: IMA
Dr Dilip Sarda, president of IMA (Indian Medical Association), city chapter, said, ?Doctors should not mislead the patients about usage of influenza vaccine.
Before suggesting or promoting any influenza vaccine, he or she should collect information about the usage of vaccine.
How can a doctor promote a vaccine as H1N1 vaccine when it is clear that H1N1 vaccine is not available in India as yet??
Sarda added, ?When doctors mislead patients into believing that they have been administered the swine flu vaccine, they tend to be careless so far has hygiene and preventive measures are concerned. If anything happens to them, who is to be held responsible??
What the law says
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 stipulates: No person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which
?in the case of a first conviction, with imprisonment which may extend to six months, or with fine, or with both;
?in the case of a subsequent conviction, with imprisonment which may extend to one year, or with fine, or with both
Penalty
Whoever contravenes any of the provisions of this Act [or the rules made there under] shall, on conviction, be punishable:
?directly or indirectly gives a false impression regarding the true character of the drug; or
?makes a false claim for the drug; or
?is otherwise false or misleading in any material particular
