High Court Directed Government to Address Price Disparities in Non-Scheduled Drug Formulations. Wide Price Variation Among Brands of Same Medicine Held to be a Matter of Public Concern Requiring Government Intervention Under Rule 10(b) of Drugs (Prices Control) Order, 1995.

High Court: Bombay High Court Bench: NAGPUR In Favour of Prosecution
  • 1
Judgement Image
Font size:
Print

Case Note & Summary

The writ petition, filed as a public interest litigation, brought to the court's attention the stark and arbitrary price differences in identical drug formulations sold by various pharmaceutical companies across India. The petitioner, through the annexed list, demonstrated that drugs such as Cetrizine, Ciprofloxacin, Gabapentin, and many others were available at prices ranging from a few rupees to several hundred rupees for the same strength and quantity, depending solely on the manufacturer. For instance, a 10-tablet strip of Flunarizine 10 mg for migraine cost Rs. 19.90 from one company and Rs. 52.00 from another; a vial of Zoledronic Acid 4 mg for cancer treatment was priced at Rs. 2,800 by Cipla and Rs. 12,500 by Novartis. This enormous disparity was alleged to be a result of the absence of price regulation for non-scheduled formulations and the unfettered discretion of manufacturers to set retail prices. The petitioner contended that this practice violated the public's right to affordable healthcare and urged the court to direct the government to exercise its powers under the Drugs (Prices Control) Order, 1995 (DPCO). The respondents, including the Union of India through its ministries, the National Pharmaceutical Pricing Authority, and the State drug authorities, were impleaded. The Union of India, represented by its counsel, argued that the petitioner had not formally approached the pricing authority with these discrepancies, and therefore the authority had no occasion to invoke its suo motu review powers. The State and its food and drug administration officials did not raise any substantial objection to the factual matrix. The High Court, after hearing the amicus curiae and counsel for the parties, examined the scope of Rule 10(b) of the DPCO. This rule empowers the government to fix or revise the retail price of any formulation, whether scheduled or non-scheduled, if it considers it necessary in public interest. The court found that the drugs listed were indeed non-scheduled and that the price disparities were prima facie excessive and detrimental to public interest. It held that such practices are a matter of public concern and that the government is duty-bound to consider intervention when public interest is at stake. Consequently, the court did not delve into the merits of specific price hikes but instead directed the respondent authorities to treat the petition as a representation, consider the price discrepancies enumerated in the list, afford an opportunity of hearing to the petitioner and the manufacturers concerned, and pass a reasoned order in accordance with law within six months. The respondents were also ordered to file a compliance report with the court. The rule was made absolute with no costs. The judgment underscores the regulatory role of the state in ensuring that essential medicines are accessible at reasonable prices, and that the DPCO provides a potent tool to curb exploitative pricing in the pharmaceutical sector.

Headnote

A) Drugs Law - Price Control - Power to revise retail price of non-scheduled formulations in public interest - Drugs (Prices Control) Order, 1995, Rule 10(b) - The Court, upon noticing a wide disparity in prices of identical drug formulations manufactured by different companies, held that such price variation is a matter of public concern under Rule 10(b) - Directed the respondent authorities to consider these discrepancies, hear the petitioner and manufacturers, and pass a reasoned order within six months, submitting a compliance report to the Court (Paras 4-7).

Subscribe to unlock Headnote Subscribe Now

Issue of Consideration

Whether the wide disparity in prices of the same drug formulations from different manufacturers constitutes a matter of public interest warranting government intervention under Rule 10(b) of the Drugs (Prices Control) Order, 1995.

Subscribe to unlock Issue of Consideration Subscribe Now

Final Decision

The High Court directed respondents to consider the price discrepancies, hear the petitioner and manufacturers, and pass a reasoned order within six months; compliance report to be submitted to the court.

Law Points

  • Government has power under Rule 10(b) of Drugs (Prices Control) Order
  • 1995 to revise retail price of any formulation including non-scheduled formulations in public interest
  • wide disparity in prices of identical drugs is a matter of public concern.
Subscribe to unlock Law Points Subscribe Now

Case Details

2010 LawText (BOM) (06) 157

Writ Petition No. 3256/2007

2010-06-23

S. A. Bobde, A. B. Chaudhari

Mr. A. A. Naik, Ms Tajvar Khan, Mr. P. D. Kothari

Shri Bharat Kandhari

Union of India, National Pharmaceutical Pricing Authority, State of Maharashtra, Commissioner Food & Drugs Administration Maharashtra, Joint Commissioner Nagpur Division, Zota Pharmaceuticals Pvt. Ltd., Serdia Pharmaceuticals, Sanofi Aventis, G.S.K. Pharma, F.D.C. Pharmaceuticals Ltd., Biochem Pharmaceuticals, Blue Cross Laboratories Ltd., Panacea Biotech Ltd., Aventis Pharma India Ltd., Jajsonpal Pharmaceuticals, Nicholas Piramal India Ltd., Core Pharmaceuticals, Aristo Pharmaceuticals Pvt. Ltd., Johnson & Johnson, Glenmark Pharmaceuticals Ltd., USV Ltd., Intas Pharmaceuticals Ltd., Sum Pharma, Pfizer, Cipla Pharmaceuticals Ltd., Ranbaxi Laboratories Ltd., Dr. Reddy’s Laboratories Ltd., Novartis Health Care Pvt. Ltd., Torrent Pharmaceuticals, Zydus Cadila, Ethnor India Ltd., R.K.G. Pharma Pvt. Ltd., Micronova Pharmaceuticals Ltd., Cadila Pharmaceuticals Ltd., Winsome Laboratories Pvt. Ltd.

Subscribe to unlock Case Details (Citation, Judge, Date & more) Subscribe Now

Nature of Litigation

Public interest litigation seeking regulation of prices of various drugs and medicines

Remedy Sought

The petitioner sought direction to the respondents to consider and rectify wide disparities in prices of drugs manufactured by different companies.

Filing Reason

The petitioner brought to the court's notice a list of drugs showing significant price variation between brands of the same formulation, which imposed heavy burden on patients.

Issues

Whether the wide disparity in prices of the same drug formulations from different manufacturers constitutes a matter of public interest warranting government intervention under Rule 10(b) of the Drugs (Prices Control) Order, 1995.

Submissions/Arguments

Petitioner/Amicus: Pointed out wide price disparities and that patients are often forced to buy expensive brands, urging intervention under Rule 10(b). Respondents 1&2: Argued that discrepancies were not brought to authorities' notice, so no occasion to exercise power under Rule 10(b).

Ratio Decidendi

Under Rule 10(b) of the Drugs (Prices Control) Order, 1995, the Government may, in public interest, revise the retail price of any formulation including non-scheduled formulations. Wide variation in prices of identical drugs is a matter of public concern and the government must exercise its power to ensure medicines are available at the lowest possible price.

Judgment Excerpts

the Government may, if it considers necessary so to do in public interest, after calling for such information by order fix or revise the retain price of any formulation including a nonscheduled formulation it is clear that there is wide disparity between the prices of the same medicines because they are manufactured and marketed by different companies Such practice is a matter of public concern and certainly a matter of public interest within the meaning of Rule 10 (b) we consider it appropriate to direct the respondents to consider the discrepancy in prices of the drugs as set out hereinabove and pass a reasoned order, after hearing the petitioner and the manufacturers, in accordance with law

Procedural History

The writ petition was filed under Article 226 of the Constitution. The High Court issued rule, made it returnable forthwith, and heard the matter finally with the assistance of Amicus Curiae. No prior proceedings are mentioned in the judgment.

Acts & Sections

  • Drugs (Prices Control) Order, 1995: Rule 10(b)
Subscribe to unlock full Legal Analysis Subscribe Now
Related Judgement
High Court High Court Directed Government to Address Price Disparities in Non-Scheduled Drug Formulations. Wide Price Variation Among Brands of Same Medicine Held to be a Matter of Public Concern Requiring Government Intervention Under Rule 10(b) of Drugs (Pric...
Related Judgement
High Court Bombay High Court Allows Writ Petition Challenging Revisional Order in Co-operative Society Membership Dispute — Fraud Allegations Require Inquiry. Revisional Authority Must Consider Fraud Allegations Under Section 154 of Maharashtra Co-operative S...