Essential Diagnostic List – another step towards a Healthy India (PART II)
In the first edition of this blog, we evaluated the impact of EDL on the healthcare system. The Indian IVD manufacturers have an important role to play along with the health ministry to ensure that EDL truly benefits the patients at large. In this concluding series let us evaluate the same:
In addition to the healthcare sector, an EDL will also have a significant impact on the IVD manufacturing industry:
An EDL, by listing country/region specific needs, could help develop target product profiles (TPPs). A TPP provides details on the minimum and optimal performance and operational characteristics of priority diagnostic tests. Researchers and manufacturers use TPPs to ensure that R&D activities are focused on relevant products to meet the needs of end users. Moreover, an EDL is prepared taking into consideration, target users, intended use, infrastructural requirement, sample type and volume, sample handling, performance, diagnostic testing algorithm, etc. Thus, an IVD manufacturer can refer to this list for improvement, development and to plan production of their products considering the criticality of the assays.
Since a country’s EDL is aimed at providing affordable diagnostics, it would encourage Indian manufacturers as their cost will be relatively lower compared to the MNCs. It would bolster investments in Making in India.
As a representative of the IVD industry, I strongly recommend this initiative. Having said that, the industry seeks support from the Government in certain areas, in order to ensure the effectiveness of an EDL:
Policies and regulatory guidelines need to be articulated for grading or assessment of diagnostic assays and the related conditional recommendations, if any. For instance, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) started in the year 2000, developed and implemented a common and transparent approach to grading the quality of evidence and strength of recommendations in healthcare. This would ensure standardization of the results.
The Indian medtech industry is one of the focused areas in the Government’s ‘Make in India’ campaign. Import dependency in this sector, pegged at Rs. 25000 crores still remains the biggest challenge. Policy makers need to define ways to prefer the advanced tests developed and/ or manufactured in India, which successfully undergo GRADE methods. The indigenously manufactured devices loose out to the imported ones, due to flawed certifications, tendering norms, a skewed market place and an image perception challenge. MNCs have managed to stake claim on many government tenders which carry unfair exclusionary clauses, like mandatory compliance to USFDA. The Government needs to empower Indian Certification for Medical Devices (ICMED) and set high standards of assessments with right regulatory framework.
As mentioned earlier, the list is slated to help streamline procurement of essential diagnostics, besides encouraging local manufacturers to know exactly where to focus their R&D efforts and resources for quality supplies. By encouraging, local manufacturers into long-term contracts for bulk purchase of diagnostics, the Government can help the industry compete with Fly by Night operators.
Simply put together, the potential benefits of EDL include affordable pricing, improving regulation and quality of diagnostic tests, strengthening accreditation and quality of laboratories, improving supply chain, and guiding the R&D of new diagnostic tools. A stepwise approach for EDL implementation has been envisioned, with multiple iterations in the coming years. While the EDL explicitly defines a list of important tests required at various levels of the health care system, it is important to note that by itself the EDL cannot have an impact. It requires an integrated, tiered laboratory system, adequate human resources, training, laboratory infrastructure, and regulatory/quality assurance systems. The WHO expects the Member States to adopt and adapt the EDL, develop national guidelines and policies and devise a responsibility matrix to implement and ensure maximum output.
In addition to the healthcare sector, an EDL will also have a significant impact on the IVD manufacturing industry:
An EDL, by listing country/region specific needs, could help develop target product profiles (TPPs). A TPP provides details on the minimum and optimal performance and operational characteristics of priority diagnostic tests. Researchers and manufacturers use TPPs to ensure that R&D activities are focused on relevant products to meet the needs of end users. Moreover, an EDL is prepared taking into consideration, target users, intended use, infrastructural requirement, sample type and volume, sample handling, performance, diagnostic testing algorithm, etc. Thus, an IVD manufacturer can refer to this list for improvement, development and to plan production of their products considering the criticality of the assays.
Since a country’s EDL is aimed at providing affordable diagnostics, it would encourage Indian manufacturers as their cost will be relatively lower compared to the MNCs. It would bolster investments in Making in India.
As a representative of the IVD industry, I strongly recommend this initiative. Having said that, the industry seeks support from the Government in certain areas, in order to ensure the effectiveness of an EDL:
Policies and regulatory guidelines need to be articulated for grading or assessment of diagnostic assays and the related conditional recommendations, if any. For instance, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) started in the year 2000, developed and implemented a common and transparent approach to grading the quality of evidence and strength of recommendations in healthcare. This would ensure standardization of the results.
The Indian medtech industry is one of the focused areas in the Government’s ‘Make in India’ campaign. Import dependency in this sector, pegged at Rs. 25000 crores still remains the biggest challenge. Policy makers need to define ways to prefer the advanced tests developed and/ or manufactured in India, which successfully undergo GRADE methods. The indigenously manufactured devices loose out to the imported ones, due to flawed certifications, tendering norms, a skewed market place and an image perception challenge. MNCs have managed to stake claim on many government tenders which carry unfair exclusionary clauses, like mandatory compliance to USFDA. The Government needs to empower Indian Certification for Medical Devices (ICMED) and set high standards of assessments with right regulatory framework.
As mentioned earlier, the list is slated to help streamline procurement of essential diagnostics, besides encouraging local manufacturers to know exactly where to focus their R&D efforts and resources for quality supplies. By encouraging, local manufacturers into long-term contracts for bulk purchase of diagnostics, the Government can help the industry compete with Fly by Night operators.
Simply put together, the potential benefits of EDL include affordable pricing, improving regulation and quality of diagnostic tests, strengthening accreditation and quality of laboratories, improving supply chain, and guiding the R&D of new diagnostic tools. A stepwise approach for EDL implementation has been envisioned, with multiple iterations in the coming years. While the EDL explicitly defines a list of important tests required at various levels of the health care system, it is important to note that by itself the EDL cannot have an impact. It requires an integrated, tiered laboratory system, adequate human resources, training, laboratory infrastructure, and regulatory/quality assurance systems. The WHO expects the Member States to adopt and adapt the EDL, develop national guidelines and policies and devise a responsibility matrix to implement and ensure maximum output.
Authored By:
Dr. Manoj Chugh
General Manager - R&D (Reagents)
Dr. Manoj Chugh
General Manager - R&D (Reagents)
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