In a landmark decision, the Supreme Court of India has stayed the Central Government’s controversial order to remove Rule 170 from the Drugs and Cosmetics Rules, 1945. This rule, pivotal in regulating the advertisement of Ayurvedic, Siddha, and Unani medicines, has been a cornerstone of ensuring that misleading advertisements do not find their way into the public domain. The apex court’s decision comes as a critical development in the ongoing debate over the promotion and regulation of traditional medicine in India.
Rule 170: A Pillar Against Misleading Advertisements
Rule 170 was introduced in 2018 to combat the growing issue of misleading advertisements within the traditional medicine sector. Under this rule, no advertisement for Ayurvedic, Siddha, or Unani medicines could be published or broadcast without prior approval from the licensing authority of the state or union territory where the medicine is manufactured. This regulation aimed to prevent the public from being misled by exaggerated or false claims about the effectiveness of these medicines, which could potentially have serious health implications.
By enforcing Rule 170, the government sought to protect consumers from deceptive marketing practices and to uphold the integrity of India’s rich heritage in traditional medicine. The removal of this rule raised concerns about the potential proliferation of unchecked advertisements that could mislead consumers and compromise public health.
Supreme Court’s Reprimand of the Centre
The Supreme Court’s decision to stay the Centre’s order came during the hearing of a case involving the Ministry of AYUSH and the issue of misleading advertisements, particularly in the case of Patanjali. A bench comprising Justice Hima Kohli and Justice Sandeep Mehta expressed strong disapproval of the Centre’s actions, particularly in light of the court’s earlier order dated May 7, 2024, which clearly mandated that no action should be taken that would undermine the enforcement of Rule 170.
The court questioned the rationale behind the Centre’s decision to issue a letter on August 29, 2023, instructing states and union territories to refrain from taking action against companies under Rule 170. This move was seen as a direct contradiction to the Supreme Court’s directive, prompting the bench to reprimand the government for what appeared to be a deliberate disregard for the court’s authority.
Impact of the Court’s Stay Order
The Supreme Court’s stay on the Centre’s order effectively means that Rule 170 remains in force until further clarification is provided by the government. This is a significant win for consumer rights and public health advocates who have long argued that the removal of Rule 170 would open the floodgates to misleading advertisements that could endanger lives.
By suspending the government’s notification of July 1, 2024, which sought to abolish Rule 170, the Supreme Court has ensured that the regulatory framework governing the advertisement of Ayurvedic, Siddha, and Unani medicines remains intact. This decision underscores the court’s commitment to safeguarding public health and maintaining the integrity of India’s traditional medicine practices.
Background of the Case: The Patanjali Controversy
The roots of this legal battle can be traced back to the controversy surrounding Patanjali, a leading manufacturer of Ayurvedic products in India. Patanjali has been accused of making misleading claims regarding its products, including assertions about their efficacy in treating COVID-19 and other serious illnesses. These claims were challenged by the Indian Medical Association (IMA), which filed a petition in the Supreme Court on August 17, 2022, raising concerns about the potential harm such advertisements could cause to public health.
During the hearing on May 7, 2024, the Supreme Court questioned the Centre’s decision to issue a letter through the Ministry of AYUSH instructing authorities not to take action under Rule 170. The court’s pointed queries highlighted the seriousness with which it views the issue of misleading advertisements, particularly those that could exploit the public’s trust in traditional medicine.
The Importance of Rule 170 in Regulating Traditional Medicine
Rule 170 plays a crucial role in regulating the promotion of traditional medicines in India. Ayurvedic, Siddha, and Unani systems of medicine, while deeply rooted in Indian culture and history, must be regulated to prevent misuse and ensure public safety. These systems often rely on natural ingredients and ancient practices, which can be misrepresented or exaggerated in advertisements, leading to public misconceptions.
Without the stringent oversight provided by Rule 170, there is a risk that companies could exploit the lack of regulation to promote products with dubious or unproven claims. This could not only harm consumers who may rely on these products for serious health issues but also undermine the credibility of the traditional medicine sector as a whole.
The Centre’s Argument for Removing Rule 170
The Centre’s rationale for removing Rule 170 has been based on arguments related to administrative efficiency and the need to streamline regulatory processes. The government has suggested that the rule is no longer necessary, given the existence of other regulations that govern the safety and efficacy of medicines.
However, critics argue that the removal of Rule 170 is a shortsighted move that ignores the unique challenges posed by the advertisement of traditional medicines. Unlike allopathic drugs, which are subject to rigorous clinical trials and approvals, Ayurvedic, Siddha, and Unani medicines often rely on traditional knowledge and practices that may not be subject to the same level of scrutiny. This makes the role of Rule 170 even more critical in ensuring that these products are marketed responsibly.
The Path Forward: Awaiting the Government’s Response
With the Supreme Court staying the Centre’s order, all eyes are now on the government’s response. The court has sought a detailed explanation from the Centre regarding the rationale behind its decision to remove Rule 170 and the steps it plans to take to address the concerns raised by the court.
As the case unfolds, it is clear that the outcome will have far-reaching implications for the regulation of traditional medicines in India. The Supreme Court’s intervention has not only protected consumers from potentially harmful advertisements but also reinforced the importance of regulatory oversight in preserving the integrity of India’s traditional medicine systems.
