Recently, Ideal Cures obtained EXCiPACT certification for its Vasai manufacturing facility. It is the first Indian company to receive this certification and all its three facilities are now EXCiPACT certified. Suresh Pareek, Managing Director, Ideal Cures speaks about the recognition and its benefits, in an interaction with Usha Sharma
Ideal Cures has received EXCiPACT certification for its third manufacturing site located at Vasai, near Mumbai. Now all the manufacturing plants of Ideal Cures in India, based at Vasai, Jammu and Khambhat, are EXCiPACT certified. How will these certifications enhance the company’s brand presence in the global space?
A certificate adds credibility, good will and increases reliability factors which the customer associates with good quality. Being the first to receive the EXCiPACT certificate in India will not only create brand awareness but also enhance brand recall. I believe that EXCiPACT certificate will surely add value to our brands globally. Brand awareness is the extent to which the brand is recognised by potential customers. Certification makes customers aware of our brand and this recognition helps in the brand presence. This awareness is achieved through advertisements, participation in exhibitions, technical seminars and customer visits.
EXCiPACT has the highest standards specified for excipient manufacturers and their audits are conducted by auditors who have to undergo a rigorous assessment process in order to be EXCiPACT registered. Since, Ideal Cures is the first Indian company to receive this certification for all its manufacturing sites in India, it will definitely inculcate additional trust and confidence amongst our existing customers and also invite attention of new customers. Ideal Cures has always been a company that values quality and innovation, and this additional accreditation through EXCiPACT will certainly add value to the company’s brands in the global space.
Your company is the first recipient of EXCiPACT certification from India. What does this recognition mean to you and your staff? Will this recognition expedite the company’s business further?
Recognition to be the first Indian company to receive the EXCiPACT certification adds great sense of achievement to me as well as to all my colleagues in the company. It has built a sense of pride amongst us to be trendsetters in India and has inculcated a firm belief that with dedication, commitment and hard work, nothing is impossible. It will give confidence to the customers for doing business with the company as receiving a certificate is a stamp that the company follows GMP standards and about the standing of the company. This confidence will open opportunities from the customers who never tried our products or have been reluctant to give us opportunities.
How did your company staff prepare for the certification process? What technical aspects need to be adhered to while applying for the EXCiPACT certification? How long does the process take?
We followed the EXCiPACT standards for GMP and GDP, this works in accordance to the guideline of IPEC Europe, IPEC Americas, Pharmaceutical Quality Group (PQG), European Fine Chemicals Group (EFCG) and Federation of European Chemical Distributors (FECC).
The EXCiPACT audit process is a two-stage audit. The scope of both the audits is to confirm that the company conforms to all the requirements of the appropriate GMP/GDP legislations and guidelines for the manufacture of the desired products for use as excipients in pharma site as laid down in the EXCiPACT standard.
The complete process of certification, right from contact with EXCiPACT, application, agreement, first and second stage audits, audit reports and CAPA, up to complete certification process takes around 10-12 months for a company.
Does the EXCiPACT certification mean that the cost of normal operations, post-certification will rise as the level of compliance within the manufacturing plant has risen?
No, the overall cost of operations will not increase much while complying with the standards. Initially, getting ready for compliance with the EXCiPACT certification might have extra cost for upgrading infrastructure, recruiting manpower, pay fees to certifying agencies and training cost wherever required to formulate proper guidelines and procedure and system as set by EXCiPACT certifying authorities.
MSME has the credit linked capital subsidy scheme to provide 15 per cent upfront capital subsidy to SSI units, to help them with the costs of installing the new equipment and technology upgradation. (http://msme.gov.in/WriteReadData/Whatsnew/Sch-vol1-151214.pdf-sri.pdf).
Will the projected increase in business justify smaller companies opting for this extra cost?
For companies that are starting fresh or smaller companies, investment in manpower may increase the cost. By following the system, procedures and guidelines, ultimately the company may end up saving and providing quality products to customers, thereby increasing business.
India has the largest number of US FDA certified manufacturing plants outside the US which means that products for exports already meet compliance standards. What then is the rationale for EXCiPACT certification for excipient manufacturers, at the other end of the pharma manufacturing process cycle?
True, India has the largest number of US FDA certified manufacturing plants outside US; however these certifications are for formulators. There were no GMP and GDP guidelines to evaluate the quality of the excipients. For this reason pharma formulation manufacturers had to personally carry out audits at each of their excipient manufacturers and suppliers.
EXCiPACT uses IPEC guidelines to define GMP in its standards for excipients. The GMP guidelines formulated by the IPEC were in consultation with US FDA and European regulatory authority. Thus, certified manufacturers who comply with EXCiPACT standards in turn also comply with USP guidelines. Usually the brand of excipients used by the originator are mostly used by the generic manufacturers for their new US FDA filings. Like US FDA certification builds trust and confidence in the regulators and consumers about the standards of medicines manufacturers, in a similar manner, EXCiPACT certificate will builds similar trust and confidence with the formulation manufacturers. This is the rationale.
Since, this certification follows the procedures and standards of the GMP guidelines set by IPEC and it is also recognised worldwide, it will be a boon for the pharma excipient manufacturers as they would not have to face separate audits from its customers. The wide acceptance of this certificate will definitely save much time and energy.
Can you tell us, globally how many companies have obtained this certificate and do you foresee that many Indian companies will also opt for it?
As on July 7, 2015, 22 manufacturing sites spreading across three continents and nine countries have received EXCiPACT certification globally. These sites are located in countries like Canada, Belgium, Germany, France, India, The Netherlands, Saudi Arabia, Spain and the UK.
When someone starts a trend others follow it, if it has benefits. Earlier, I remember ISO certification was done by only a few companies. Companies who didn’t have ISO felt left out initially, but eventually when they understood the importance of implementing ISO standards they joined in. Take another example of US FDA certification, you yourself mentioned that India has largest number of US FDA certified manufacturing plants outside of US. If I remember correctly, Ranbaxy was the first Indian company to receive FDA certification for its manufacturing facility and now there are 28 facilities in Maharashtra itself that are US FDA certified. Why did they do it? The answer is that they realised the benefits of following and implementing systems and getting certified, and I am sure having US FDA certification has given them a status and recognition of being reliable on a global scale.
With this in mind, I certainly foresee that EXCiPACT certification will also become the highest standard for excipient manufacturers and eventually they will follow this trend set by Ideal Cures in India and get their excipients manufacturing sites certified by EXCiPACT. As per information gathered, four to five companies in India have already started compliance levels and have scheduled the pre-check audits of EXCiPACT.
Since three of your manufacturing facilities have already obtained EXCiPACT certifications, will you consider mentoring/ guiding other excipient manufacturers aiming for EXCiPACT certification?
We would be very happy to mentor and guide other excipient manufacturers who wish to acquire EXCiPACT certification and I would also be happy to help in my personal capacity to the excipient manufacturers. Our team has spent more than around 10 months in the process of obtaining the certificate and we will be glad to share our experience, guide the prospective applicants with the infrastructure that needs to be developed to meet the requirements and documentation that needs to be done for audits of EXCiPACT.
For general information, I lay down some of the steps that I would like to share for getting the certification:
First stage: The company should be ISO9001:2008 certified from approved agencies, comply with the current GMP/GDP practices, before applying for EXCiPACT standards. Having the ISO certificate also means that the basic GMP standards are already followed by the company irrespective of the business. If this is not the case
then the company must first get the ISO certification and the first step towards that is appointment of a consultant who will guide, help and mentor the company in getting such ISO certification. The MSME also has schemes like ISO 9000 certification reimbursement scheme to provide incentive to small scale units for expenditure subject to a maximum of Rs 75,000/- incurred for obtaining ISO certificate.
Second stage: After having the ISO certification, the EXCiPACT GMP and GDP guidelines as laid down by the IPEC federation should be followed.
How will this recognition drive investment to our country and boost the ‘Make in India’ initiative launched by PM Narendra Modi?
To me, the ‘Make in India’ initiative of Prime Minister Narendra Modi does not only mean that it has to drive investment to our country. As I see, the ‘Make in India’ campaign has many aspects, first where Indian companies in different sectors and areas produce and make goods and products which are of good quality with competitive costs for our own consumption. thus substituting imports and saving foreign exchange. Secondly, it also means, to my understanding that whatever is made in India, the Indian companies are able to export outside the country, thus earning foreign exchange as well as increasing brand value of Indian products in India and abroad.
Both these aspects would also mean investment is made and employment is generated. Coming to the question of driving investment to our country; once the investors have trust, confidence and assurance of quality they will certainly invest in India.
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