The High Court of Jammu and Kashmir and Ladakh on Friday closed a Public Interest Litigation (PIL) seeking to prevent the supply and availability of spurious and fake drugs in J&K.
A division bench of Chief Justice Arun Palli and Justice Rajnesh Oswal disposed of the PIL after the government informed it that ample measures had been taken to ensure the availability of quality medicines and drugs to the patients in J&K and that in case there is any compliant appropriate action in accordance with law would be taken.The PIL filed by Naveed Riaz, a practicing lawyer, had also urged to conduct of large-scale sampling tests for the medicines available in the market on a regular basis in accordance with the provisions of the Drugs and Cosmetics Act, 1940.
The petitioner had also sought the court’s intervention for an immediate ban on the sale and distribution of drugs manufactured and distributed by unregistered companies and urged legal proceedings against the erring companies and individuals.
Besides devising a strategy for controlling the counter sale of antibiotics and other drugs and making it imperative to sell drugs only on a medical prescription, the PIL had called for steps to spread awareness among the masses about the drugs through seminars, television, public debates, newspapers, the internet, and radio.
In their response to the PIL, the authorities said that the Drugs and Cosmetics Act and the rules framed thereunder lay down a comprehensive mechanism with all checks and balances to regulate the sale and purchase of medicines.
“The manufacturer of drugs is under a statutory obligation to test each lot of the raw material used for manufacturing drugs and each batch of the final product. Besides, the Drug Control Department lifts samples of drugs randomly as well as on the basis of complaints from the vendors,” they said.
While the authorities reported to the court that J&K has two testing labs, one each at Srinagar and Jammu, they said, “Intelligence cum legal cell has been created vide a government order dated November 26, 2018, to facilitate busting of spurious drug rackets and the prompt prosecution of perpetrators of crime under the act.”
In the report, the authorities further mentioned the number of samples tested during the last five years and the administrative actions and prosecutions launched by them.
Further, they said that the petitioner had not gone through the “label claims” of medicinal preparations, “which are governed by Rules 96 and 97 of the Drugs Rules, 1945.”
“Every drug manufactured in India shall bear on its label the number of the license under which the drug is manufactured, the figure representing the manufacturing license number being preceded by the words ‘Manufacturing License Number’ or ‘Mfg Lie No’ or ‘ML.’”
“Besides the name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured, the label carries a distinctive batch number – the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken,” the authorities said.
They said that through the department’s website, there is a proper complaint redressal mechanism and all the complaints received are attended to to the entire satisfaction of end-users.
J&K has to broadly rely on manufactures’ in-house testing and the regulatory mechanism available within the respective states from where manufactured drugs enter J&K.
“The department has carried out extensive market checks and found that the drugs in circulation are manufactured by companies having established credentials,” the authorities said.
However, out of abundant caution, notices have been served upon all the companies regarding which the petitioner has cast doubts.
The authorities said that there was no fake entity engaged in the pharmaceutical business as per the market survey.
“Checks and counter checks are already in place, and the manufacturing of drugs is an activity regulated by many regulations in addition to the Drugs and Cosmetics Act, 1940,” they said.