There has been quite a buzz about “Make in India” campaign – launched by our Prime Minister, Shri Narendra Modi, to encourage companies to manufacture their products in India. His purpose behind the campaign is to achieve US $30 trillion GDP for India by 2030.
For this, he focused on 25 different sectors that can contribute to increasing GDP and tax revenues. Amongst which Pharmaceuticals is the one!
Why Pharmaceuticals?*
So, here are the major reasons:
- India is expected to rank amongst the top three pharmaceutical markets in terms of incremental growth by 2020.
- India is the sixth largest market globally in terms of size.
- India’s generic drugs account for 20% of global exports in terms of volume, making the country the largest provider of generic medicines globally.
- India’s cost of production is significantly lower than that of the USA and almost half of that of Europe.
- A skilled workforce as well as high managerial and technical competence.
- Economic prosperity is likely to improve affordability for generic drugs in the market.
- Approval time for new facilities has been drastically reduced.
Also, as per statistics:
- The country’s pharmaceuticals industry accounts for about 2.4% of the global pharma industry by value and 10% by volume.
- Industry revenues are expected to expand at a CAGR of 12.1% during 2012-20 and reach USD 45 Billion.
- The healthcare sector in India is expected to grow to USD 250 Billion by 2020 from USD 65 Billion currently.
- The generics market is expected to grow to USD 26.1 Billion by 2016 from USD 11.3 Billion in 2011.
What are the challenges?
Driving pharmaceutical industry is a tough row-to-hoe. Being multifaceted in nearly all segments, the industry becomes quite complex.
Formula Management
Numerous multi-level formulas that altered continuously to meet the ever-changing consumer requirement needs to be documented. Every information, including ingredients involved, their amount used, storage conditions, manufacturing process, COA, pH values, etc. has to be recorded. Maintaining and managing these is a complex task to perform. And, failure to meet the challenge could result in non-compliance. Ultimately, arises the risk of product being pulled from the market.
Adequate Inventory Management
Effectively managing adequate inventory, along with tracking its expiration is difficult for manufacturers. They need to assure that adequate amount of inventory is available at the required time and ensure that it is not close to the expiration. Failure to perform this may result in money loss and could even claim a life.
Title 21 CFR Part 11 Management
The U.S. Food and Drug Administration has set the following criteria: “Electronic records, electronic signatures, and handwritten signatures executed to electronic records [must] be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”[Source: https://www.dionex.com/en-us/webdocs/114284-TG70216_CM7_21-CFR-Part-11_R4.pdf]. And, Pharmaceutical companies have to remain in compliance with this regulation.
Production Transparency & Traceability
Managing production with proper insights of exactly what happened and when is the important to achieve proper and timely production. Tracing items right from its entry as raw material, processing, to its exit as finished good plays an important role in data accuracy, quality control and performing recalls. Although important, but tough to meet for manufacturers.
Quality Control
Producing consistent, high quality yet compliant products is another challenge for Pharmaceutical industry. They need to make sure that each step of production is quality checked, results are properly tracked, and corrective actions are taken, if required.
The best way to meet these challenges is to implement an ERP solution to automate every step of operations.
How ERP & Vertical-Focused Solutions Will Help?
Knowing the fact – “one size doesn’t fit all”, ERP Software for Pharma Industry will be apt. The vertical solution provides end-to-end supply chain management capabilities to manufacturers and distributors. Numerous inbuilt features provide remarkable control over multilevel formulas, keeping adequate inventory, bi-directional lot traceability, and just-in-time manufacturing.
Using the vertical solutions, manufacturers can easily comply with FDA audits and validation, 21CFR Part 11 electronic signature, and conform to cGMP requirements. Quality Inspection Plans for keeping monitoring information of the batch, adverse event reporting, CAPA, production and scheduling plans, tracking expiry, and secured R&D are the other features of BatchMaster that can help pharmaceutical manufacturers to excel their production.
BatchMaster as a company serves & strengthens the pharmaceutical companies based & manufacturing in India with our ERP solutions & Pharma specific solution suite.
