Recently The Drug Price Control Order DPCO 2013 has exempted innovative patented drug from the price...........

Governance Issues Health

Recently The Drug Price Control Order (DPCO), 2013 has exempted innovative patented drug from the price control regulations. In this context consider the following statements.

1. If a pharma company discovers a new process to make an existing drug and gets a patent for it under the Indian law, it can apply for a five-year relaxation from price regulation

2. Exemption would be valid for five-year from the date it starts producing the drug.

Select the statement which is/are correct.

1 only

2 only

Both 1 and 2 only

Neither 1 and 2

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Explanation:

Three types of innovation can qualify for exemption:

If a new drug has been developed using indigenous research and development and has been granted a patent under the Indian law, it can seek exemption from price control from the date, when it starts commercial production in the country and not from start producing.

Second, if a pharma company discovers a new process to make an existing drug and gets a patent for it under the Indian law, it can apply for a five-year relaxation from price regulation

Finally, a finished drug which uses a new delivery system (such as controlled release or sustained release) developed through domestic research and development would also be eligible for exemption from price control.