 "Govt justifies drug ban to Delhi HC")
The Delhi High Court heard the government's stand today on the banning of 344 fixed dose combinations (FDC's) previously licensed and marketed by manufacturers.
Pursuant to a report submitted by the Kokate Committee established by the Health Ministry, the central government had by notification on March 10 banned the specified FDC's on the grounds of safety and efficacy.
The move with its potentially huge financial implications was immediately challenged by some of the pharmaceutical sectors largest manufacturers leading to a flood of petitions in the High Court.
Advocate Rajul Jain, appearing for the Union of India made an impassioned plea highlighting the necessity and reasonability of the notification. He said: "This exercise (ofidentification and banning) in itself is required to be taken frequently (bythe government)" in light of general public interest."
He further requested the court for a purposive interpretation of the Act in line with the vision of the legislators and the social objective sought to be achieved.
The court in turn questioned the authority ofthe government to make such notifications and frame rules with retro-activeoperation outside of the provisions of the Act. "Can it be so (the power tomake rules), without statutory provisions" Justice Rajiv Sahai Endlaw asked.
While defending the power of the government the arguing counsel referred to various provisions of the Drugs and Cosmetics Act,1940 and rules framed there under.
He drew the attention of the court to Section26A which enshrines the powers of the Central Government to prohibit manufacture, etc., of drugs in public interest and Section 33(2)(e) which allows for rules to be made by the Central Government for cancellation orsuspension of licenses if provisions of the Act (or rules) are not complied with.
The government advocate also highlighted the distinction between 'licensing' and 'approval' and submitted that there could be no valid license without approval as required by the rules. He further contended that any license required renewal every five years and that the affected companieshad approached state licensing authorities for renewals without first complying with approval requirements.
After hearing the submissions, the court asked the government to consider if any legal lacuna had remained in their stance and whether the situation could be remedied by any appropriate action. The court continued the interim relief previously awarded to the petitioners and listed the matter for further hearing on May 5.
On a parting note, Justice Endlaw issued aword of concern on the present situation calling it a "Very dangerous thing, aswe don't know how many others (unapproved drugs) there are (in the market)."
Pursuant to a report submitted by the Kokate Committee established by the Health Ministry, the central government had by notification on March 10 banned the specified FDC's on the grounds of safety and efficacy.
The move with its potentially huge financial implications was immediately challenged by some of the pharmaceutical sectors largest manufacturers leading to a flood of petitions in the High Court.
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The court first heard the matter on March 14 and provided interim relief by staying the applicability of the impugned notification. The petitioners on the ground that the drugs in questionhad been in the market for the last 25 years and the notification issued by the government did not disclose any grave urgency.In today's hearing, the government was allowed the opportunity to justify the ban before the court.
Advocate Rajul Jain, appearing for the Union of India made an impassioned plea highlighting the necessity and reasonability of the notification. He said: "This exercise (ofidentification and banning) in itself is required to be taken frequently (bythe government)" in light of general public interest."
He further requested the court for a purposive interpretation of the Act in line with the vision of the legislators and the social objective sought to be achieved.
The court in turn questioned the authority ofthe government to make such notifications and frame rules with retro-activeoperation outside of the provisions of the Act. "Can it be so (the power tomake rules), without statutory provisions" Justice Rajiv Sahai Endlaw asked.
While defending the power of the government the arguing counsel referred to various provisions of the Drugs and Cosmetics Act,1940 and rules framed there under.
He drew the attention of the court to Section26A which enshrines the powers of the Central Government to prohibit manufacture, etc., of drugs in public interest and Section 33(2)(e) which allows for rules to be made by the Central Government for cancellation orsuspension of licenses if provisions of the Act (or rules) are not complied with.
The government advocate also highlighted the distinction between 'licensing' and 'approval' and submitted that there could be no valid license without approval as required by the rules. He further contended that any license required renewal every five years and that the affected companieshad approached state licensing authorities for renewals without first complying with approval requirements.
After hearing the submissions, the court asked the government to consider if any legal lacuna had remained in their stance and whether the situation could be remedied by any appropriate action. The court continued the interim relief previously awarded to the petitioners and listed the matter for further hearing on May 5.
On a parting note, Justice Endlaw issued aword of concern on the present situation calling it a "Very dangerous thing, aswe don't know how many others (unapproved drugs) there are (in the market)."