The Hon. (Dr.) Nalinda Jayatissa - Minister of Health and Mass Media and Chief Government Whip

¶ 01 Hon. Deputy Speaker, responding also to points raised by Hon. Ajith P. Perera:

¶ 02 We must ensure continuous supply of safe, quality medicines at fair prices, both within the public system and at fair prices outside it. The NMRA Act mandates quality, safety, and price regulation; Section 3(a) provides the legal basis to make safe, effective, correct, and affordable medicines and medical devices available to the public. Section 118 allows appointment of a Pricing Committee; Section 118(2)(b) enables price fixation.

¶ 03 Several Gazettes were issued after enactment: e.g., 21 Oct 2016 setting prices for 48 medicines; 14 Dec 2017 increasing those by 5%; 15 May 2019 extending to 60 items. Later, in 2019, the Sri Lanka Chamber of the Pharmaceutical Industry challenged NMRA’s price-fixing power; interim injunction was refused, so NMRA proceeded to gazette MRPs at times (e.g., 19 Aug 2021 +9%; 15 Mar 2022 +29%; 29 Apr 2022 +40%; 15 Jun 2023 -16%).

¶ 04 Subsequently, the Chamber again went to the Court of Appeal, arguing that without a published pricing formula NMRA could not regulate prices. The Court granted an interim order restraining price control. NMRA then published a pricing formula; importers challenged it again, saying stakeholders were not consulted as required under Section 118(4) (“after consulting all such persons…”). On Attorney-General’s advice, the earlier Gazette was withdrawn.

¶ 05 On 21 July 2025, Gazette 2446/34 was issued after stakeholder consultations, and the interim order was vacated. Importers and the pharmacy owners’ association filed again seeking interim relief against price control; courts declined. Hence we now seek Parliamentary approval of the Regulations gazetted on 2025.10.07.

¶ 06 The framework sets: - Maximum Retail Price (MRP): per individual product, using a formula considering CIF, tariff/duties, supply-chain transport and labour costs, and reasonable margins. - Maximum Ceiling Price (MCP): a category-wide price cap, generally aligned around the median price within approximately 85% of market incidence.

¶ 07 New NMRA registrations or renewals will adhere to both MCP and MRP bands, with consideration of prevailing local prices and source-country prices. A company disagreeing with a proposed cap may appeal within defined timelines (typically 3–4 months). Registration proceeds only upon agreeing to quality and price conditions. Thus, not just 48 or 60 items—future registrations broadly align to this structure.

¶ 08 We will review MRPs semi-annually. If extraordinary macroeconomic shifts occur—e.g., sharp exchange-rate movements—we are prepared to revisit values transparently. If an existing MRP lies above MCP, it must be reduced to at or below MCP; if an MRP is already below MCP, MCP will not be raised merely to match it.

¶ 09 Non-compliance can trigger action under Section 131 of the Act.

¶ 10 On NMRA capacity: When we took office, there were over 2,100 pending files; by 01 January it was 1,589; we have since reduced the backlog further, including medical device files (over 2,019 then, now significantly cleared). Staff increased from 119 to 216. Monthly testing increased from ~60 to ~280–300. Upgrades are underway with ADB/WHO support towards WHO and ISO certifications.

¶ 11 On reported shortages, e.g., “100 items at Nagoda”: hospitals routinely submit weekly or biweekly shortage/low-stock lists via the Chief Pharmacist to the Medical Supplies Division (MSD). The current list from Nagoda includes around 428 items and several surgical consumables combined—these are live operational documents used to trigger central issues and local purchases. We have allocated funds for local purchases to bridge gaps when central stocks are pending.

¶ 12 Examples: For Ipratropium, the order was placed on Jan 21; tender closed on Mar 21; awarded Jun 06; 160,000 units received by Oct 16 with further tranches due. For Heparin: order placed Apr 26, 2024; delivery due Oct 27 this year. Typical lead time from MSD indent to SPC supply can be ~9 months. We accelerated tenders: SPC spent Rs. 48 billion last year; as of mid-October this year, Rs. 80 billion already disbursed with ~Rs. 30 billion more planned—reducing reliance on local purchases.

¶ 13 We caution against stoking public fear; it can cause hoarding or altered dispensing (e.g., reducing multi-month insulin issues), and can distort private-market prices. NMRA, SPC, SPMC, and MSD are coordinating closely.

¶ 14 Regarding vehicle windshield designation stickers for doctors/lawyers: Government has not taken any decision to remove such identification aids used for access/security and emergencies. No directive from Motor Traffic or Police to ban them. They facilitate identification and access.

¶ 15 We are committed to uninterrupted, quality, affordable medicines for the public. Thank you.