By Arsh Rampal
The Government of India is soon planning to enforce a new code to regulate marketing practices in the pharmaceutical sector. The existing Uniform Code of Pharmaceutical Marketing Practices (UCPMP) was published in 2014, but it was voluntary, and not mandatory. The new draft code shall carry a force of law and includes better enforcement mechanisms.
Background
India currently does not have any specific law to regulate the marketing practices of pharmaceutical companies. The previous code, which is in existence, was not mandatory and thus there was no enforcement mechanism in place to ensure that pharmaceutical companies comply with it. The larger companies found it easier to follow the code. The small and medium-sized enterprises in the sector, however, had difficulties doing so. The government has therefore planned to bring in a mandatory code of conduct to regulate marketing practices. The enactment of a binding framework has faced several delays. In August this year, an earlier draft of the code was sent back by the Law Ministry for not being aligned with the legal framework of the Essential Commodities Act.
Why does it matter?
The use of unethical practices to market pharmaceuticals is a problem that needs to be tackled on an urgent basis. The healthcare system in our country needs to be made more affordable to benefit the masses. A significant factor that contributes to the prices of medicines is the marketing practices used by pharmaceutical companies. Unethical practices employed by these companies can cause a substantial rise in the prices of these drugs. These costs can easily be avoided by better regulation of marketing methods. A mandatory code in place also ensures that all pharmaceutical companies shall comply with it and there would be no discrepancies in the application of the law.
Essential features
The new code includes many features to ensure that unethical methods are not adopted while pharmaceutical companies promote their product to health care providers. It aims to regulate a large number of practices adopted by the pharmaceutical marketing companies. Companies are now required to back up any claim relating to the utility of the drug with substantive evidence. There is particular information that mandatorily needs to be provided by pharmaceutical companies while promoting products. Free sampling of drugs will be brought down and regulated heavily to ensure that the health and safety of citizens are not compromised easily. It aims to target the practices of giving gifts and other benefits to health care providers and their families.
Pharmaceutical companies spend a significant amount of money on providing incentives to health care providers and their relatives. The bill includes various provisions that deal with a wide range of incentives that are generally offered by pharmaceutical companies. Tackling this issue will cause a significant drop in the prices of these drugs. It will also help increase financial accountability and transparency in the commercial relationship between the pharmaceutical company and health care providers.
The future outlook
It has been a long time since the UCPMP was first published, and the need for strengthening it has been highlighted by lack of enforcement mechanisms in place. The enactment of a mandatory code has been delayed by a long time and even now the expected date of adoption is in question. Recent policies and events, however, show that the enactment of this code will come soon. Upon adoption, the Bill will have a significant impact on increasing accountability and transparency on the part of both the pharmaceutical industry as well as healthcare providers.
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