Last Updated on August 13, 2023 by The Health Master
Availability of Scheduled Formulations
The National Pharmaceutical Pricing Authority (NPPA) has taken significant steps to oversee the discontinuation of scheduled formulations from the market, aiming to ensure the availability of essential drugs for the public.
In a recent update, the NPPA revealed that it received a total of 226 intimations under Form IV for discontinuation of scheduled formulations between April 1, 2020, and July 31, 2023.
Out of these, the authority has given approval to 157 cases, indicating careful consideration of each application.
Let us examine this trend in more detail and the steps the NPPA has taken to keep drugs available.
Discontinuation Trends Over the Years
In the financial year 2022–23, the NPPA approved 27 Form IV intimations.
Interestingly, most of these approvals came with a directive for the manufacturers to continue production until specific months in the year 2023.
This is a strategic move to ensure a seamless transition without compromising the availability of essential medications.
Comparing this to previous years, the NPPA approved 48 Form IV intimations in the financial year 2021–22 and 36 in the financial year 2020–21.
Notably, in the latter year, the 36 Form IV filings encompassed requests to discontinue a total of 81 compositions.
This shift in discontinuation trends underscores the NPPA’s commitment to preserving drug accessibility while accommodating manufacturers’ needs for discontinuation.
Para 3 Invocation for Continued Production
Over the last three financial years, the NPPA invoked Para 3 in four cases.
This provision has been instrumental in ensuring the uninterrupted production of essential drugs.
Para 3 serves as a mechanism to extend the period of continued production beyond one year from the intended discontinuation date, if deemed necessary in the public interest.
This step underscores the NPPA’s holistic approach to maintaining a stable drug supply.
Regulatory Framework for Discontinuation
The Ministry of Chemicals and Fertilizers, which oversees the operations of the NPPA, emphasized the importance of the regulatory framework in ensuring drug availability.
The Drugs Price Control Order (DPCO) 2013 contains Paragraph 21(2), which stipulates that manufacturers intending to discontinue scheduled formulations must intimate the government through Form IV of Schedule-II of the DPCO at least six months prior to the intended discontinuation date.
This proactive measure allows ample time for regulatory adjustments and planning to prevent abrupt drug shortages.
Diving into specific approvals, Baxter Pharmaceuticals India Pvt. Ltd. emerged as a prominent player in the discontinuation landscape.
In the years 2022–23, the NPPA granted approvals for discontinuation requests submitted by Baxter.
These included products such as:
- Sedoz 1mg injection,
- Sucrofer 20mg injection,
- Zepita, Panisa,
- Profol 10 mg.
The company justified its discontinuation requests on the grounds of financial viability and sustained losses in its Indian operations due to elevated costs.
Addressing Unique Cases
The NPPA also addressed unique cases where discontinuation was influenced by factors like market share and demand.
Kedrion Biopharma India Private Limited, New Delhi, received approvals for discontinuation due to stakeholders’ decisions to exit the Indian market.
Similarly, Unison Pharmaceuticals, based in Gujarat, secured approvals for its levofloxacin and ondansetron formulations, citing low market share and insufficient demand as reasons for discontinuation.
Indoco Remedies Ltd., Mumbai, saw approvals for its Clamchek 625 tablets, AXL 500 mg capsules, and OH-D3 capsules.
The decisions were driven by decreasing sales and diminished value.
Neon Laboratories Ltd.’s Form IV intimations for erythropoietin injection and timolol maleate eye drops were approved due to their insignificant market share.
Pfizer Products India also received approval for discontinuing Cyklokapron 100 mg, as the company acknowledged its minimal market share for the product.
Ensuring Uninterrupted Drug Availability
Minister of State in the Ministry of Chemicals and Fertilizers, Bhagwanth Khuba, emphasized that the NPPA’s approval of Form IV intimations is contingent on specific criteria.
These approvals are granted when the market share is not significant, and there are an ample number of other players in the market.
Importantly, the absence of complaints regarding the non-availability of scheduled drugs in the past two financial years reflects the effectiveness of the NPPA’s strategies in maintaining drug accessibility.
Through careful scrutiny of Form IV intimations, invoking Para 3 when needed, and adhering to regulatory protocols, the authority strikes a balance between manufacturers’ interests and public health needs.
This proactive stance not only prevents sudden drug shortages but also fosters a stable and reliable drug supply chain.
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