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Industry concerned over delays in review applications under DPCO 2013
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Shardul Nautiyal, Mumbai
September 03 , 2024
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The pharmaceutical industry in the country has voiced concern over the handling of review applications under the Drugs (Prices Control) Order (DPCO) 2013, citing prolonged delays, operational disruptions, and a lack of transparency in the process. These grievances, raised by industry leaders, have called into question the efficacy of the review mechanism provided under Paragraph 31 of the DPCO 2013.
According to the stipulated provision, any individual or organization aggrieved by a notification or order issued under paragraphs 4, 5, and 6 of the DPCO 2013 has the right to apply for a review. This review process is critical for maintaining fair market practices, ensuring compliance, and upholding regulatory justice. However, pharmaceutical companies argue that the execution of this process has been far from efficient or timely.
A primary concern raised by pharmaceutical companies is the delays in the processing and issuing of review orders. According to recent data, it takes anywhere from five months to over a year after the review hearing for the Department of Pharmaceuticals (DoP) to upload the orders on its website. Such delays, companies argue, are unacceptable and undermine the principle of timely justice.
A senior executive from one of the affected pharmaceutical companies, who preferred to remain anonymous, stated, "These delays are harming our business operations. We are left in limbo, unable to proceed with our plans and having to navigate the uncertainty without clear guidance or decisions from the authorities."
Under the current DPCO guidelines, pending a decision by the government on the review application, no manufacturer is permitted to sell a scheduled formulation or a new drug at a price exceeding the ceiling price set by the government. This requirement, while intended to regulate pricing and protect consumers, has inadvertently created financial challenges for companies awaiting review decisions. The inability to market and sell products at desired prices during the prolonged review period has resulted in financial losses and market instability.
A spokesperson from another major pharmaceutical company emphasized, "The delayed issuance of review orders directly impacts our bottom line. The uncertainty makes it difficult to plan product launches, manage inventory, and forecast revenues. We urgently need a more predictable and timely review process."
In addition to delays, the pharmaceutical companies have raised concerns about a perceived lack of transparency in the review process. They argue that the inconsistencies and delays in issuing orders without clear communication or justification create a perception of unfairness and erode trust in the regulatory framework.
A regulatory affairs expert, commented, "The lack of transparency in the review process is a significant issue. When there is no clear communication or rationale for the delays, it leads to speculation and mistrust. A transparent and predictable review mechanism is essential to maintaining confidence in the regulatory system."
To illustrate the extent of the problem, pharmaceutical companies provided examples of specific cases where delays were particularly egregious:
A review application submitted on April 28, 2023, had its hearing on September 25, 2023, but the order was not issued until February 7, 2024, resulting in a delay of over nine months.
Another application, submitted on January 6, 2023, with a hearing on September 25, 2023, saw the order issued on May 27, 2024, a delay stretching nearly 16 months.
These examples highlight a systemic issue affecting numerous companies across the industry, not isolated incidents. Pharmaceutical companies have urged the Ministry to take immediate corrective actions to address these concerns. Their requests include expedited processing, implementing a strict timeline for issuing and uploading review orders within one week of the review hearing. Another issue is establishing a mechanism to provide applicants with regular updates on the status of their review applications. Systematic review process is another issue. Developing a more consistent approach to reviewing applications to avoid discrepancies and ensure fairness.
In conclusion, pharmaceutical companies are hopeful that their grievances will be addressed with the urgency and seriousness they deserve. They look forward to a prompt and positive response from the Ministry, which will restore faith in the regulatory framework and ensure that the review process under DPCO 2013 is conducted fairly, transparently, and in a timely manner.
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