"The focus on innovation must change towards finding effective solutions to rampaging AMR, effective treatments for country-specific diseases with particular focus to tropical and infectious diseases, targeted delivery of existing drugs to disease-specific sites to improve efficacy and safety and drug repurposing, to name a few."
Could you tell us about the Indian Pharmaceuticals Association and its work within the industry?
The Indian Pharmaceutical Association (IPA) was established in 1939 when the pharmaceutical industry was almost nonexistent in India, including pharmaceutical education programs. The progress of the IPA as a premier association of pharmaceutical professionals in India paralleled the development of the pharmaceutical industry, as well as pharmacy education in India. Many industry stalwarts were presidents of the IPA and worked relentlessly to lay foundations for the Indian pharmaceutical industry to flourish. These industry stalwarts who headed IPA include Mr. A. V. Mody, Dr. G. B. Ramasarma, Dr. J. N. Banerjee, Dr. Parvinder Singh and Mr. Ramanbhai Patel, to name some of the significant contributors. Typically, the president of IPA or his nominee is a member of the Drug Technical Advisory Board (DTAB), the apex statutory decision-making body on technical matters related to drugs and drug regulations in India. As a member of DTAB, IPA continuously advises the Government of India on important issues related to drugs and pharmaceuticals.
How has the industry progressed since we last spoke in 2017?
Indian pharmaceutical industry growth is quite encouraging and meeting all projections and expectations. The total value of Indian pharmaceutical turnover in 2019 is expected to be over US$37.2 billion, with exports contributing US$19.14 billion and the domestic market in 2018 standing at US$18.12 billion. At this rate, the Indian pharmaceutical industry is likely to touch the US$50 billion mark by the end of 2020, in line with the expectations of a CAGR of 22%. In line with these developments, the number of regulatory agency-approved manufacturing sites, the number of ANDA filings and ANDA approvals are all on the rise.
India is currently the largest producer of generics in the world. What improvements can be made in terms of production within India?
India, popularly referred to as the Pharmacy of the World, makes a significant contribution through the supply of quality generics and vaccines to almost all countries around the globe. The Indian pharmaceutical industry must keep pace with global competitors to maintain its position as the world’s largest generic drug supplier by improving regulatory compliance of manufacturing sites and developing cost-effective and high-quality manufacturing processes. To consolidate and sustain its global leadership position, India needs to reduce dependence on imports for APIs, key intermediates and starting materials. It is also necessary for the Indian industry to become fully compliant with the Track and Trace requirements being imposed by various regulatory agencies to ensure quality pharmaceutical imports and to prevent counterfeiting. The Indian industry needs to diversify and focus on other important areas such as drug substances, complex generics, biosimilars and biologics, medical devices and diagnostics, herbals and traditional Indian medicinal products such as AYUSH products. There is tremendous scope in these areas either to reduce import dependence or increase share of exports to other countries. The government must support these initiatives through incentives and providing the required infrastructure and clearances at a faster rate.
Could you speak of the industry shift towards innovation?
Innovation is the key to industry growth and to sustain the heights achieved. The Indian industry has made significant developments in the areas of non-infringing formulations and biologics, including vaccines and biosimilars. However, innovation is often thought to be synonymous with new drugs developed and launched. The Indian industry made attempts at new drug discovery and development, but successful launch of a new drug is a very long process. Given that, Indian efforts in the area of new drug discovery still fall below the industry averages, expecting successes in this domain at the current effort levels is unrealistic. However, a lot needs to be done in the area of innovation by the Indian industry and Indian academic research. The focus on innovation must change towards finding effective solutions to rampaging AMR, effective treatments for country-specific diseases with particular focus to tropical and infectious diseases, targeted delivery of existing drugs to disease-specific sites to improve efficacy and safety and drug repurposing, to name a few. It is also essential that significant efforts be made in developing cost-effective and environmentally friendly processes for synthesizing APIs and key intermediates. The industry should also focus more on standardization and quality assurance of herbals and AYUSH products to increase India’s share of the global herbal and phytopharmaceutical market.
How have new governance and changes in the regulatory framework impacted the pharmaceuticals industry?
The Government of India introduced several initiatives intending to improve the health of India and strengthen its manufacturing industry. Pradhan Mantri Bharatiya Janaushadhi Pariyojana is a major initiative aimed at making quality medicines available to the public at affordable costs. The Make in India campaign is aimed at creating the infrastructure necessary for making India the manufacturing destination of the world for all equipment, goods and commodities. In line with achieving this objective is the Skill India campaign implemented through the National Skill Development Corporation and its various sector skill development councils. The objective is to develop skills in people aspiring for industry jobs, as well as those who are already employed in various industries, to create employable human resources as well as to enhance the quality of production. In the field of pharmaceuticals, regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO) and various state licensing authorities are expanding their headcount and operations as well as digitalizing their activities to build the efficiencies that are necessary to meet the needs of the rapidly growing pharmaceutical industry. SUGAM online portal of the CDSCO is for online applications, granting of permissions and to track the status of applications. The DAVA portal is meant for drug authentication and verification of batch number and manufacturer of that drug. CDSCO also came up with guidelines for biologics and biosimilars, medical devices and new guidelines for clinical trials.
Moving forward, what are the key objectives of the IPA?
IPA’s current focus is to ensure that there are well-trained pharmacists in places where medicines are handled. To this end, IPA is involved in advocacy measures directed towards emphasizing the need and value of pharmacists. IPA believes that to provide quality health care services, pharmacists should be continuously trained. Through our pharmacy practice divisions (Community Pharmacy and Hospital Pharmacy), IPA is involved in organizing training programs to the community and hospital pharmacists all over the country. Areas of focus include rational use of medicines, containing antimicrobial resistance, building awareness towards detection of spurious and fake medicines, patient counseling, reduction of medication errors, good pharmacy practices and so on. IPA is working towards convincing the government to make pharmacists an integral part of the healthcare initiatives and has been successful in demonstrating their value in detection and monitoring treatment goals of tuberculosis and AIDS. IPA also places a lot of emphasis on motivating and creating future leaders from the pharmacy students all over the country through the student forum (IPASF) platform. We also work closely with international organizations such as FIP, CPA, FAPA, and SEARPharm Forum to ensure that a well-trained pharmacist is behind each medicine prescribed to encourage better health outcomes. In conclusion, the key objective of IPA is to position pharmacists as one of the most important healthcare providers in our country.