Last Updated on January 13, 2024 by The Health Master
The Department of Pharmaceuticals (DoP) is planning to rope in reputed agencies to work with the Government of India for conducting short-term and long-term studies and submit the report on pharmaceutical and medical devices sector, to help it frame policies, monitoring and corrective measures.
The first two topics in the short-term studies for which it has floated RFP include tracking of medicines across the supply chain and assessing skill requirements of the Indian pharma industry, both for a duration of three months.
As the pharma industry in the country has around 60,000 products and presence of eight lack retailers, the envisaged track and trace system by way of QR codes faces various difficulties by industry including accommodation of the code on the strip given constrained space availability, parent-child linkage, financial, technical and logistics issues.
The C-19 pandemic has shown the need for timely identification of stocks at state, district and retailer level and re-emphasises the need to establish capabilities to track flows of essential products at all stages.
First study: The scope of the work include assessment of modes and nodes across the supply chain for medicines, identification of inefficiencies across such nodes and modes, evolve strategies to track medicines across the supply chain to ensure availability of medicines down to the retailer and recommending implementation of strategies that that may encompass a statutory framework or a voluntary mechanism by industry based on cooperation.
Second study: The second study, on assessment of skill requirements of the Indian pharma industry, is to identify the underlying factors with respect to the demand-supply mismatch as against opportunities for post graduates and doctorate holders from NIPERs in the Indian pharma industry. The time frame of this study is also three months.
Long term studies: For the long-term studies, it has proposed eight topics, including a four month study on the impact of DPCO 2013 on the prices of cardiac stents, knee implants and six medical devices – oxygen concentrators, pulse oximeter, glucometer, BP monitor, nebuliser and digital thermometer on the industry and consumers in terms of availability and affordability, to assess the impact of price control on medical devices and equipment on the industry and consumers in terms of availability and affordability.
Second study on assessment of procurement of medical devices in the public sector (Central Government), to recommend regarding the medical devices for which the domestic value addition is less than 25 per cent and ways to improve the same. The timeframe of the study is four months.
Third Study: The third proposed study, in a timeframe of four months, is a survey of medical devices clusters, evaluating their contribution to overall production, supplies and exports, assessment of infrastructure and logistics framework and suggest improvements and providing recommendations to cost efficiency and cost competitiveness of clusters.
Fourth Study: The fourth study is a survey on pharma clusters, in four months, to evaluate contribution of these clusters to overall production, supplies and exports, assessment of infrastructure and logistics framework and suggest improvements, provide recommendations to boost efficiency and cost competitiveness of clusters.
Fifth Study: The fifth study, for a timeframe of six months, is on the uniform code for pharmaceutical marketing practices, a study of Indian experiences as against best global practices, to recommend steps for better implementation of the UCPMP to achieve a more efficient outcome.
Sixth Study: The sixth study, for six months, is an analysis on leveraging the patent cliff, with drug sales worth $251 billion going off patent as the pharmaceutical sector in the country will undergo landmark changes in the year 2021, as a number of drugs are expected to go off-patent and make entry in the market as generic products. The study is expected to recommend actions and roadmap for implementation with regard to each stakeholder to actualise the potential identified.
Seventh Study: The seventh study, a survey for novel, innovative and cost-effective technologies for route of synthesis to decrease cost of production of active pharmaceutical ingredients which are currently being imported to reduce import dependency, which may recommend on establishing industry-academia engagement and networking for development and commercialisation of API related technologies, has a timeframe of four months.
Eighth Study: The eight topic, is to develop a strategy for leveraging the ASEAN Free Trade Agreements and trade potential with the Middle East countries for pharma sector in the country, which includes terms of reference to recommend strategies to leverage ASEAN FTA and potential trade with Middle East countries in fuller measure keeping in view the strengths of the Indian industry. The timeframe for this study is six months.
Licensing procedure for manufacturing of Drugs
The studies will be conducted under the Pharmaceutical Promotion and Development Scheme (PPDS), which is set up for promotion, development and export promotion in the pharmaceutical sector by extending financial support for conduct of seminars, conferences, exhibitions, and conducting studies and consultancies for the growth of the industry.
“Reputed agencies will be selected by DoP for conducting various studies and submitting reports thereof for effective creation and utilisation of database of pharmaceutical and medical devices sector, production/manufacturing, EXIM, raw material availability etc., which will help in framing the policies, monitoring and corrective measures, if necessary, or any other purpose deemed necessary,” said the Department. It has invited Request for Proposal (RFP) from reputed empanelled agencies with the Government of India for conducting studies and submitting reports.
The selection process would be based on a technical evaluation and a financial evaluation. The agency should be an empanelled agency with the government and has experience of at least three years whose turnover in the last financial years was not less than Rs. 20 lakh.
Successful bidders shall submit a comprehensive report, both in physical and electronic form within three months as per the Scope of the Study, to the satisfaction of the DoP. A pre-bid meeting will be conducted on November 10, to explain the scope of tender and other details.
The bids must be submitted and received by DoP on or before 3 pm, November 17, 2021. Technical bids will be evaluated on November 23, from 12 pm and those RFPs comply with the technical bids requirement and eligible for financial bids will be opened on 3 pm, on November 25.
The DoP has also announced conditions for work-order and agreements, termination of contract/work-order, it’s right to terminate the RFP process and the right to reject any or all proposals. The DoP shall also reserve the right to impose a penalty for delay in submission and poor quality of the report, up to 10 per cent of the work-order value. There are also terms for disqualification and dispute resolution in the invitation of RFP.
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
Govt to amend New Drugs & Clinical Trials Rules
Indian Pharma industry needs to address climate change challenges
Anti-Covid drug manufacturers move to CDSCO for permission
Ketamine abuse linked to damage of this organ: Read details
Govt takes important decisions on Pharma & Medical Devices Industry
Govt issued notification for Form 29: License to Mfg drugs for…
NFI 2021: Salient features of 6th Edition of National Formulary of India
Govt releases draft policy for R&D, Pharma and Medical Devices
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
