Lynk Insights Q&A with Knowledge Partner: Vivek Padgaonkar on India Pharma Policymaking

What are your primary  policymaking concerns in the pharmaceutical industry?
My primary  concerns in the Indian healthcare industry are access to healthcare and affordable medicines, ensuring safety and quality of the medical products manufactured, imported and distributed in our country.

There have been numerous internal and external challenges today for the Indian pharma industry; more from the external point of view when consider global scrutiny, especially from the regulatory agencies. The quality issues which exist in India are actually happening throughout the world, thus, the need for more stringent regulations and stricter pricing, which are fundamental to the healthcare industry worldwide.

Have there been any recent innovations that have allowed for improved policymaking in the Indian pharma industry?
Yes, namely the introduction of the following three policies that are proving to be gamechangers in the Indian pharma industry:

New Drug Exemption and Orphan Drug Exemption:
From 2019, the Government has exempted manufacturers, importers and marketers of patented new drugs from price control for a period of five years (“New Drug Exemption”). The Government has also exempted such drugs from price control, qualifying as Orphan Disease in the opinion of the Ministry of Health and Family Welfare (“Orphan Drug Exemption”). As a consequence of the policy, manufacturers of new drugs patented in India will be free to price the drugs for a period of five years from the date of commencement of commercial marketing of the drugs.    

Clinical Trial Waiver:
For orphan drugs, used in the treatment of rare diseases, clinical trials will be waived if the drug is approved outside of India already. Besides, companies may not have to pay an application fee for seeking approval to conduct clinical trials in India. The other key provisions include fast-tracking of clinical trial  approvals for other drugs within 30-90 days and statutory norms for payment of compensation in case of injury or death during trials

What are three trending technological innovations in the pharma industry that you would like highlight?
1. Eisai Pharma : Quicobal Orally Disintegrating Strip
EP positions “neurology” and “oncology” as two strategically important areas where they can research and explore into truly unmet patient needs. Quicobal has the essential nutrient that helps the body to produce healthy red blood cells and nerve cells, whilea also exerting  a repairing effect on injured nerve tissues.

2. Schott Kaisha: Patented Nano Technology
SK has been  amongst the first in the world to introduce new products like nested or  bulk sterile vials and cartridges, over and above existing portfolio for sterile nested syringes in the Indian market. In its efforts to contribute to the fight against spurious and counterfeit injectables, SK has introduced for the first time in India, color markings, like OPC dots, identification bands, graduation, etc. With SK’s patented nano technology, when under a special laser, the genuineness of the product can be easily determined.

3. Glenmark Pharma: MDI Digital Inhalation: Digihaler
Glenmark Pharmaceuticals  has developed “Budesonide + Formeterol MDI Digital Inhalation” under the brand Digihaler. Although the product  has no additional therapeutic advantages, the presence of digital dose counter would help the patients in getting accurate measurement of dosage, low dose warning LED, end of dose  display etc.

What are your thoughts on the Knowledge-as-a-Service economy?
A knowledge economy is the production of goods and services based on knowledge-intensive activities that contribute to an accelerated pace of technical and scientific advancements. It will continue to bring changes to the way we live, work, and operate businesses. Information Systems in the field of Knowledge Management has becomes a game now changer thanks to the advacenements in BigData and AI.

The well-known four pillars of the KaaS economy: (i) regulatory regimes, (ii) education and human resources, (iii) information infrastructure, and (iv) innovation systems.

What do you like about working with expert networks?
I am glad to provide access to the relevant  knowledge in the most efficient ways which will enable short term and long term impacts on the industry, ensuring the upholding of regulatory compliance .

Naturally , I do feel proud of the brand of KaaS companies when they provide my knowledge input as a solution to save clients from various blockers.


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