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The coronavirus disease 2019 (COVID-19) pandemic highlighted the world's level of preparedness in managing public health emergencies (PHEs). It revealed the critical need for timely medical therapeutics, especially vaccines. To expedite response, many nations, including India, adopted emergency approval mechanisms and offered new ways of review, such as the rolling review along with the accelerated review procedure. This response resulted in reallocating internal resources and adopting new policies and measures, such as integrating digital technology with regulatory submissions and flexibility in statistical approaches. The present review focuses on the utilization of the New Drugs and Clinical Trials Rules 2019 for granting emergency approval to COVID-19 vaccines by the Drug Controller General of India (DCGI) and explores the legislative basis for such authorization during the PHE. The review aims to elucidate key intricacies and challenges inherent in the existing 'emergency use' framework within the Indian regulatory landscape. It assesses three critical facets of the 'emergency use' paradigm: the definition of the term, establishment of a transparent decision-making process, and formulation of rules governing termination or expiration of the emergency status. It makes policy recommendations regarding the 'emergency use' framework to respond to new, emerging, or re-emerging public health threats of the future. [ABSTRACT FROM AUTHOR]

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the 'Compassionate Use' or 'Expanded Access' mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish 'win–win' situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries. [ABSTRACT FROM AUTHOR]

Geographical indications (GI) rights are unique as they have a regio‐cultural basis and involve the knowledge and skill of communities. The enactment of the Indian GI Act 1999 was aimed to improve the economic status of the communities and key products for export by registration of GI. Analysis of the inspection body particular, institutional mechanism, and registration process revealed the need for elaboration of GI protection mechanism. Of particular significance is the need to protect the reputation of GIs, strengthen the local registration mechanism, and identify a mechanism for monitoring and conservation of GI. Analysis of food GI such as Bardhaman Sitabhog and Mihidana provide insights on the need for an enhanced protection mechanism to be provided under the GI Act and the rules which have a significant bearing on the post GI sustenance. [ABSTRACT FROM AUTHOR]

Promotion of genetic engineering research and encouraging GM crops can help to overcome the future deficit of food production in India. Hunger, poverty, malnutrition etc. are significant problems that still need to be addressed. "The National Food Security Act, 2013" is expected to resolve some of these challenges. The country's agricultural GDP need to be augmented by the increase in food crop production. Regulation of transgenic plant research is guided by several legislations in the country. Policy and social considerations related to GM crops continue to be a popular debate in the country. Regulatory agency approvals impact commercialization of transgenic crops. As greater capacity continues to develop in transgenic research on plants in Asia one of the prime considerations is whether Indian legislation and regulation adequately promote transgenic plant research. The present study maps and analyses various legislations that are involved in the research to commercialization of transgenic crops. The suggested framework will serve as a ready reckoner for firms practicing in this area. [ABSTRACT FROM AUTHOR]

Objectives: To assess the constraints for Indian herbal drug industry with respect to manufacturing and commercialization of herbal medicines. Methods: A questionnaire-based survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from 150 companies by email, telephone, and in-person interviews from June 2009 to August 2010 and were analyzed to draw appropriate conclusions. Results: The survey result showed that differing regulatory requirements and the limited market in foreign countries are the major hindrances for exporting. Standardization and quality control of raw materials and herbal formulations emerged as the major challenge for Indian herbal drug manufacturing firms. Insufficient regulatory guidelines, particularly guidelines for good manufacturing practices; nonimplementation of good agricultural and collection practices; and weak implementation of the Drugs and Cosmetics Act of 1940 are considered major drawbacks for the Indian herbal industry. Conclusions: Proper implementation of the Drugs and Cosmetics Act of 1940, development of more elaborate guidelines on quality control aspects, and development of marker-based standards are needed to produce safe and effective herbal medicines in India. Because evidence-based studies are becoming increasingly essential for establishing the safety and efficacy of herbal products in the domestic and export market, more focus should be placed on scientific and technological advancement in the field of herbal medicine. Regulatory harmonization becomes essential to mitigate the delays in commercialization across countries. [ABSTRACT FROM AUTHOR]

The recombinant drug industry is growing at almost 20% rate in India. The long term growth of this sector depends upon innovation, competition and market. The structure, conduct and performance of firms in market play a very important role in predicting the future of innovation and competition in market. The present paper analyses the structure-conduct-performance paradigm in the context of recombinant drug sector in India. The analysis reveals that advertisement, distribution chains, and R&D have significant effect on the profits of firms in the recombinant drug sector. [ABSTRACT FROM AUTHOR]

Abstract: Ethnopharmacological Relevence: Herbal drugs are gaining worldwide prominence due to their distinct advantages. Developing countries have started exploring the ethnopharmacological approach of drug discovery and have begun to file patents on herbal drugs. The expansion of R&D in Indian herbal research organizations and presence of manufacturing units at non-Indian sites is an indication of the capability to develop new products and processes. The present study attempts to identify innovations in the Indian herbal drug sector by analyzing the patenting trends in India, US and EU. Methodology: Based on key word and IPC based search at the IPO, USPTO, Esp@cenet and WIPO databases, patent applications and grant in herbal drugs by Indian applicants/assignees was collected for the last ten years (from 1st January 2001 to 31st October 2010). From this collection patents related to human therapeutic use only were selected. Analysis was performed to identify filing trends, major applicants/assignees, disease area and major plant species used for various treatments. Result: There is a gradual increase in patent filing through the years. In India, individual inventors have maximum applications and grants. CSIR, among research organizations and Hindustan Unilever, Avesthagen, Piramal Life Science, Sahajanand Biotech and Indus Biotech among the companies have the maximum granted patents in India, US and EU respectively. Diabetes, cancer and inflammatory disorders are the major areas for patenting in India and abroad. Recent patents are on new herbal formulations for treatment of AIDS, hepatitis, skin disorders and gastrointestinal disorders. Conclusion: A majority of the herbal patents applications and grants in India are with individual inventors. Claim analysis indicates that these patents include novel multi-herb compositions with synergistic action. Indian research organizations are more active than companies in filing for patents. CSIR has maximum numbers of applications not only in India but also in the US and EU. Patents by research organizations and herbal companies are on development of new processes for active compound isolation and standardization of such components in addition to new compositions for therapeutic use. Pharmaceutical companies such as Ranbaxy, Lupin and Panacea Biotec are increasingly patenting on herbal drugs. There is increased patenting activity related to diabetes, cancer, cardiovascular diseases, asthma and arthritis in India and abroad. [Copyright &y& Elsevier]

The article discusses a study which examined intellectual property rights (IPR) activity in the agricultural machinery sector in India. Pre-harvest and post-harvest operations in India have been mechanized, leading to several benefits including increase in productivity and improvement in cropping intensity. The three major patenting areas related to agricultural machinery in India are irrigation, plant growth, and post-harvest processing.

Vaccines produced by genetic engineering techniques are known to have lesser side effects and greater stability. There are 12 companies producing recombinant vaccines in India. The present study attempts to analyse the patenting portfolio and firms strategies in the recombinant vaccine sector in India. Most of the granted patents in India are on combination vaccines and the other major areas of focus are related to vaccines for Dengue, Tuberculosis, Cancer, Hepatitis and bacterial infections. Sixty-eight per cent of the patents granted on recombinant vaccines in India are owned by companies and 32 per cent of the patents are owned by research institute. In the post product regime there is increase in patent filing in India by both Indian and foreign companies. [ABSTRACT FROM AUTHOR]

Abstract: The present study attempts to analyze the patenting activity of antifungal drugs in the pre and post TRIPS period in India. There is a general increase in patent filing in antifungals both by Indian as well as by multinational companies, with greater filing by the latter in the post-TRIPS era. The major filings in the transition and post-TRIPS period have been due to increased product than process patent filings, wherein 75% of the total patent applications in this sector is directed towards product patents and remaining 25% is directed towards process patents. It is observed that Indian academic institutions have been more active than foreign institutions with respect to patent filings in this field. [Copyright &y& Elsevier]