Regulatory compliances for pharmaceutical companies in India | Compliance automation software for pharma industry

Report

Indian pharmaceutical industry supplies over 50% of global demand for various vaccines, 40% of generic drug demand in the US and 25% of all medicine in the UK. India’s pharmaceutical exports is expected to be at $55 billion by 2020. India’s domestic pharmaceutical market turnover reached Rs 129,015 crore in 2018.

Over the last few years, Pharma companies in India have seen several issues with US Drug Regulator with respect to Compliances. There have been multiple instances of warnings, observations, import alerts among others leading to loss of licenses and business.

Compliance is on top of the industry’s agenda.

Case Study

Our client is a leading multinational pharma company established in 1901 with 43,000 employees in 60 countries worldwide. They produced 120 billion tablets & capsules in 2018. The company is geographically spread with 12 offices in India. They are globally one of the leading manufacturers of API (Active Pharmaceutical Ingredients)

Our client operates in one of the most dynamic environments. In addition to a complex Indian statutory compliance environment, our client is also subject to US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA). The client was faced with several issues as given below:

3 Legal Entities, 8 Plants, 1 R&D Center across 6 States in India resulted in a highly complex compliance environment. Our Client was using spreadsheets and emails to manage their compliance
Poor understanding of various industry specific acts specially Drugs and Cosmetics Act and various other acts related to Clinical Research
Lack of clarity on a comprehensive list of applicable licenses, registrations, permissions, approvals, consent orders and their current status
Manual search for applicable Legal Updates across Central and 5 States
No Central document repository of all Compliance documents
Several instances of financial penalties on account of delays and missed compliances
Multiple instances of missed display compliances
Lot of time spent on getting status of compliances across the company

Our client is a large and complex multinational company. They needed a compliance automation solution which could help them bring greater control over applicability, legal updates and real time status tracking. They were headquartered internationally and had a number of compliances driven from the parent. In addition, they were responsible to USFDA and other European Regulators which also required meticulous tracking and management.

TeamLease Regtech Engagement

TeamLease Regtech engaged with the client in June 2018. A team of 3 Compliance subject matter experts visited their Mumbai based head office for a period of 1 week to conduct a thorough review of their business presence across India.

The implementation of AVACOM (TeamLease Regtech Compliance Automation Solution) was initiated in July, 2018.

Phase 1 - Business Discovery

This phase of the project focussed on understanding their business to establish the applicability of Acts and Compliances. Comprehensive information was collected via in-person interviews / meetings / discussions with the Board & Management, individual department heads, and other representatives in the company. The following items were collated:

Business Set up (Group, Entities, Locations, clients, number and nature of establishments, Industry, export)
Products (API Manufacturing)
Equipment & Machines (Boilers, Pressure Vessels, Gas Holders, Chimneys etc)
Establishment Types (Factories, R&D Center, Corporate Office etc)
Mandatory repeatable items driven from their global headquarters
Internal Compliances (FDA, EMA, ISO Certifications etc)

Client Facts

Multinational Pharma Company
Listed on NASDAQ
Global leader in production of API
Operates in 60 countries around the globe
43,000 employees worldwide
8 Plants, 3 offices, 1 R&D Center
Operates in 6 States in India

Project Highlights

140+ Applicable Acts
5,275+ Compliances
850 Event-based compliances
263 Users
12 Weeks to go live

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Phase 2 - Compliance Applicability Assessment

TeamLease Regtech identified several Boilers, Pressure Vessels, Hoists and Lifts, Lifting tools and tackles, Gas Cylinders, Static and Mobile Pressure Vessels, Petroleum Storage Tanks, Chemical tanks, ETP (Effluent Treatment plant) & STP(Sewage Treatment Plant) among others. This equipment were located in various plants based in 8 locations leading to applicability of different Acts and Compliances.

The team identified over 140 applicable Acts with over 5,275 applicable compliances including time based and on-going compliances.

Phase 3 - Implementation

TeamLease Regtech assigned a 4 member team of subject matter experts to work with the client. The client was keen to implement the product in phases. Our team worked collaboratively with the client and developed a 3 month long implementation plan. The plan included physical visits to 6 states and 8 cities. Here are the key activities undertaken during the implementation phase:

Map the Client Organisation (Group, Entities, Sub-Entities, Locations, Departments)
Review of identified applicable Acts and Compliances with respective department heads
Discuss identified gaps with department heads and compliance head
Map Compliances to specific users based on their roles
Hands on training sessions with user groups based on their locations and roles
Activation of system for a predetermined go-live date

A total of 263 users were mapped and trained over a period of 12 weeks for Performer, Reviewer, Approver and Management Roles.

In Conclusion

It has been over a year since the client has been on the system.

The client has reported a significant maturity in their organisational compliance program. They have seen over 50% reduction in missed compliances. In addition, the Compliance officer now has access to real time status of over 5,000 compliances without spending any non-productive time in follow ups. The assurance provided to the board has become more transparent and credible. There is a tangible reduction in their penalties and interest expenses arising out of delays. Our client is now on top of all the legal and regulatory changes within 24 hours of the release of the notification.

Our client has successfully migrated to a predictable, process oriented and digital compliance management environment.