GoI criticised for failing to finalise the drug policy

The Supreme Court criticised the government for failing to finalise the drug pricing policy which has been pending since 2003. [For Deccan Herald (“DH”) news report, see here] According to DH, the Court remarked that the issue which has been pending since 2003 was a “slur on the face of all stake-holders”. The Additional Solicitor General Sidharth Luthra reportedly submitted that the Group of Ministers (“GoM”) which discussed the proposed drug policy in its meetings could not arrive at a final decision. According to DH, the submission drew immediate and strong words from the Bench. The Bench noted that the letter pertaining to the deliberations was not carrying any details. (The Bench reportedly remarked: “Was it a silent meeting? The letter states nothing about the deliberations by the GoM or the status of the proposed policy. Did they actually deliberate or the honourable ministers were meditating during the meeting? You don’t talk when you meditate, right?”) The Court observed that it would consider passing an Order bringing all 348 drugs set out in National List of Essential Medicines (“NLEM”) under the price-control policy. The court, however, placed the matter for further hearing on September 27. (The NLEM, which was released in 1996 and subsequently revised in 2003, is meant to achieve a balanced healthcare delivery system in the country. It inter alia includes accessible, affordable quality medicine at all the primary, secondary, tertiary levels of healthcare.)

The GoM, led by Agriculture Minister Mr. Sharad Pawar later met to consider the retail pricing mechanism for essential drugs. Although it could not arrive at a conclusive decision, the GoM reached at a broad consensus on the extent of regulation. It was agreed that the price regulation will be limited to a) 348 bulk drugs and their 652 specified dosage formulation as specified in the NLEM and b) will not include their combinations. The GoM wanted to study the mechanisms in other developing countries such as Mexico, South Africa, Bangladesh and Sri Lanka before finalising the policy on drug pricing in India. The data was, however, unlikely to be available before the forthcoming hearing of the Supreme Court on September 27. The GoM is expected to suggest a new mechanism shortly for setting the prices of essential medicines. [For news reports, see here and here.]

Presently, the government controls the prices of 74 drugs through National Pharmaceutical Pricing Authority (“NPPA”). NPPA is an organization of the Government of India which was established, inter alia, to fix/revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country under the Drugs (Prices Control) Order, 1995.

On the issue of affordable medicines, it may be pertinent to note the following observations made by IPAB in its recent Order rejecting the petition of Bayer Corp., which sought a stay on the Order of the Controller granting compulsory licence to Natco Pharma.: “Therefore, the right of access to affordable medicine is as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them and further, it would in effect amount to deciding the main petition itself. Though this is not a reason why we are not granting stay, yet this is an additional factor." [See here for our analysis.]