New Delhi: The Delhi High Court has asked the Union ministry of health and family welfare to frame a policy of online sale of drugs within four months and warned that this would be the last and final opportunity for the Ministry for the same.
The order was issued by a division bench comprising Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora following the Ministry’s request to allow four more months for framing the policy for online sale of drugs as per the draft notification issued more than five years back, owing to complex nature of the matter. The draft notification for online sale of drugs was issued on August 28, 2018.
The Ministry, in its appeal requesting further time, submitted that the subject of online sale of drug is one of complex nature and any modification in the manner of sale of drugs will have far reaching consequences and will involve changes in many other Acts and Rules/Regulations apart from Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Pharmacy Practice Regulations, 2015; Indian Medical Act, 1956; Code of Ethics Regulations, 2002, and Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.
“It is further submitted that the modifications will also involve changes and amendments in these Acts and Rules/Regulations and the manner in which these Acts and Rules/Regulations are operated and enforced by all their respective stakeholders,” added the Ministry.
In view of the submission, the division bench said that it is giving the Ministry the last and final opportunity to frame the policy within four months.
“It is made clear that if the draft policy is not prepared before the next date of hearing, this Court will have no other option but to proceed ahead with the matter,” added the division bench in its order on March 4, 2024. The matter is listed now on July 8, 2024.
The Ministry has been seeking extension of time for framing the policy in the past several hearings and the High Court in its previous hearing on the matter, in November, 2023, gave an ultimatum to the Centre to frame the policy in eight weeks, noting that the Centre had sufficient time to frame a policy as five years have lapsed after publishing a draft notification regarding this.
The orders are issued on a petition filed by Dr Zaheer Ahmed, Delhi-based South Chemists and Distributors Association (SCDA) and others against the Central Government not taking action on the e-pharmacies, among other requests.
In the previous hearing, the Court had also directed that in the event the said policy is not framed within the stipulated period of eight weeks, the Joint Secretary dealing with this policy, shall be personally present in Court on the next date of hearing. The Joint Secretary was personally present in the hearing on March 4, 2024.
The drug regulator also conducted meetings with All India Organisation of Chemists and Druggists (AIOCD) leaders, Pharmacy Council of India (PCI) President Montu Kumar Patel, leaders from the SCDA, and representatives from almost all the e-pharmacy firms including Tata 1mg, Pharmeasy, Netmed,Flipkart, Practo, in August, 2023 on the matter.
AIOCD, the pharma traders national body, appealed to the drug regulator to set aside the draft rules on online pharmacy sales published in 2018, and initiate action against the e-pharmacies immediately.
The Central Drugs Standard Control Organisation (CDSCO) last year informed the Court that it has received various representations, views, suggestions, objections from different quarters and stakeholders including non-government organisations, civil societies, trade unions, chemists and druggists associations etc on the draft notification. The majority of the representations from various stakeholders had opposed the said draft rules of online sale of drugs.
It has also informed the Court that the regulator, following the order from the Delhi High Court on December 12, 2018 – which injuncted the e-pharmacies from online sale of medicines without licence and directing the regulator to ensure that the same is prohibited forthwith until further orders – it has communicated to the State and Union Territory drug regulators to implement the direction through letters on May and November, 2019 and in February 3, 2023. The DCGI also issued show-cause notices to almost 20 e-pharmacies as part of this in 2023, according to reports.
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