The Commerce Ministry will soon take a call on whether Indian pharma companies should join pharma regulator Pharmaceutical Inspection Co-operation Scheme (PIC/S) or not. Joining PIC/S will endorse Indian pharma companies as reliable exporters of quality medicines. However, meeting PIC/S’ regulatory requirements is not going to be a cakewalk, especially for companies in the MSME pharma segment, who will have to invest to upgrade their facilities. Therefore convincing the apprehensive players is going to be an uphill task for the Ministry as well as industry organisations representing them.
GMP trainers and regulatory experts are also crucial as they will have to train and prepare pharma companies and their personnel to upgrade to PIC/S’ expectations. Joining PIC/S is therefore a challenging task for all stake holders but there is consensus that not joining PIC/S will create bigger hurdles.
PIC/S should thus be seen as a huge leap towards global acceptance. If the Indian pharma industry wants to be global, it needs to think global. Pharma operators, industry organisations, regulators, GMP trainers give their opinion on this issue
By Sachin Jagdale
The process of becoming a member of PIC/S (accession) can be a long and tedious, it can take up to a maximum of six years. Going through this process forces a re-examination of the current regulatory system, how is it organised or should be organised; what are the conflict of interests and how these are addressed, inspectional procedures, etc. Preparing for the accession will force certain improvements in India’s GMP inspection system and procedures as well as improve its emphasis on Quality System requirements. These efforts also help to improve harmonisation and efficiency.
According to the information on the PIC/S website (29 April 2015) the following applicants are being considered Brazil/ANVISA, Croatia/HALMED, Hong-Kong SAR/PPBHK, Iran/MoH, Mexico/COFEPRIS, Philippines/PFDA, Thailand/Thai FDA, and Turkey/TMMDA. And, the pre-accession process is ongoing for Belarus/MoH, Chile/ISP, and Kazakhstan/ CCMPA.
Quoting Mahatma Gandhi, “We but mirror the world. All the tendencies present in the outer world are to be found in the world of our body. If we could change ourselves, the tendencies in the world would also change. As a man changes his own nature, so does the attitude of the world change towards him. This is the divine mystery supreme. A wonderful thing it is and the source of our happiness. We need not wait to see what others do.”
India need not to wait to see what others do – the reason for submitting India’s regulatory system to the scrutiny of an International Standard such as PIC/S should be for the right reasons – our families and their well-being in India.
India has emerged as a ‘power-house’ of pharma manufacturing and a recognised supplier of affordable medicines around the globe. She aspires to be “pharmacy to the world”. To be legitimate in this claim India must have one quality standard for both, the domestic and the export market. Maintaining two different quality standards – a lower standard for domestic vs a higher standard for export markets (e.g., countries members of PIC/S) is not acceptable on any grounds.
It is now the right time to provide our own families in India with medicines made to the same standards as the ones we export to US or Europe or Estonia, or Indonesia (all PIC/S members). Maintaining two different standards, I believe, is proving to be more costly (in terms of money, credibility and peace of mind) than having one – internationally recognised (or peer reviewed by other ‘competent authorities’ ) – standards.
This is an opportunity for the Indian pharma sector to establish itself as reliable drug supplier in India and abroad. To be successful, plan each step carefully – let not internal misalignment add to a difficult accession process. Do it for the right reasons – our families in India who deserve assurance of quality, safety and efficacy. This journey can also provide India with time to reflect and to position other indigenous medical paradigms (e.g., Ayurveda) more appropriately in the overall healthcare system.
– Ajaz S Hussain, Insight Advice and Solutions LLC, Frederick, Maryland, US
“There is nothing wrong with change…If it is in the right direction.” – Winston Churchill
Pharmaceutical Inspection Convention was established by European Free Trade Association in October 1970. At that time, it was titled as a legal treaty or the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
It was started with 10 members. Then, subsequently, expanded to include other eight members till 1993. In 90s, it was realised that convention, being legal treaty had limitations to add more members and expand further. Hence, in November 1995, Pharmaceutical Inspection Co-operation Scheme PIC/S was formed. PIC and PIC scheme are floated in parallel, PIC as a treaty with legal binding within limited original members. PIC scheme with similar aim and mission with an informal arrangement and no legal bindings. PIC/S is among the health and medicines control agencies for information sharing and exchange.
The aim of PIC/S is global harmonization of health and regulatory inspection procedures by establishing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, to enhance mutual confidence.
Till date, there are 46 members of PIC/S with almost all major health agencies of developed nations already being members or willing to be member. Now, Indian government started thinking to be an applicant for PIC/S membership. It’s great news.
The Indian pharma industry is well aware of international GMP standards for medicine manufacturing. I think, 70 per cent of the Indian pharma manufacturers from various parts of India are regularly getting inspected as per PIC/S GMP standards and accepted for the systems and procedures followed in manufacturing and supply of medicines, active ingredients, pharma excipients and medical devices.
But, if one can see at Indian health and regulatory systems. I think change, improvement and up-gradation is necessary there. Hence, PIC/S accession is a good initiative by the Indian Government. I think, this can give us an opportunity to meet the expectations of global health agencies. With increasing globalisation of pharma manufacturing, this will have great importance and create huge opportunities for Indian pharma manufacturers. During 40th anniversary of PIC/S on May 31, 2011, USFDA commissioner, Margaret Hamburg mentioned. “Today, PIC/S is more important than ever, given the realities of globalisation.”
For those willing to be part of PIC/S she further shared FDA’s experience of PIC/S accession…. “For those, who are considering becoming members of PIC/S, I want to share with you a little about FDA’s experience. Becoming a member of PIC/S was a long road for us. Our application was distinct because FDA is a very large organisation. Though not always easy, the PIC/S application process helped FDA to mature as an organisation. The process required us to engage in rigorous self-examination. We improved our quality systems, focused on gaps in our regulatory processes, and became more cohesive internally.”
For US FDA, if it was a long road then for Indian FDA; I think it is going to be definitely uphill task. But, from Indian manufacturers and industry perspective I think Indian government should take this challenge head-on to meet PIC/S requirements. As PIC/S accession takes three to four years from pre-accession application time, there will be time for small and medium manufacturers to upgrade their facilities to meet PIC/S GMP standards. This will help them to be competitive player in the global business.
With PIC/S accession, Indian FDA’s GMP regulations shall become globally acceptable. I think Indian government should definitely go ahead; Indian drug industry shall wholeheartedly support the mission.
– Santosh Savarkar, Associate Vice President – Regulatory Affairs, Alembic Pharmaceuticals
I would like to say that, as per directions of the Commerce Ministry, Pharmexcil has sponsored a study on this subject to IMS India. The draft report of IMS India was discussed on 27 April, 2015 in the Ministry of Commerce & Industry. All government agencies like DoP, MoH, DCGI and national associations like IPA, IDMA, Pharmexcil have participated in the discussion. It is generally felt that while the approach to join PIC/s is good in the interest of nation and particularly Indian exports, a careful examination is needed and if decided to implement, adequate time (five to 10 years) and adequate financial support to pharma companies at affordable cost should be provided by the government. The whole subject is at a preliminary stage and we are hopeful that the government will take appropriate decision with full involvement of pharma industry from all sectors.
– Dr PV Appaji, Director General, Pharmexcil
In her speech given during the 40th anniversary of the international GMP inspectorate scheme addressing a gathering of regulators in Geneva in 2011, the then US FDA commissioner Margaret Hamburg had put forward a very pertinent point stating that no one country is capable of inspecting the world on its own.
Due to increasing pressure of operating costs, many manufacturers and distributors across the regulated markets have decided to relocate to countries with less active engagement in drug quality assurance. This fact, coupled with the realities of globalisation, has made it important for a lot of regulatory bodies across the globe to partner with PIC/S. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.
The benefit of joining PIC/S is multi-fold for various stakeholders. For our regulators, it would range from giving our GMP inspectors a plethora of training and skill development initiatives to opening opportunities to play a pivotal role in developing and harmonising international GMP guides and guidelines. Moreover, the PIC/S is a cost-saving measure for the competent authority as they do not have to rely on sending their inspectors abroad, but can rely, if they wish, on other regulators’ reports.
For a country which is home to about 10,500 manufacturing units and over 3,000 pharma companies, this partnership does make sense. The very fact that India’s pharma exports stood at $15 billion in 2013-14 coupled with an impressive CAGR of 21 per cent over the last decade further reinforces the industry’s commitment towards abiding to global GMP requirements.
India being accredited with almost 1,105 CEPs, more than 950 TGA approvals and 584 sites registered by the USFDA leaves no doubt that our pharma industry will definitely be benefitted by partnering with PIC/S. For the industry at large the major benefits would be reduced duplication of inspections. This in addition to export facilitation and enhanced market access to other member nations will bring in a positive change. Partnering with PIC/S will further enhance our image in the global regulatory community.
Fermenta Biotech would welcome Government of India’s decision to become a member of PIC/S. This will bring in lot of value in terms of learning from such a diverse and large base of global regulators. I personally feel that this will bring up the total cumulative learning and GMP understanding of our regulators which in turn will help us build up capabilities and processes to create much more robust GMP systems across all our units.
In case of Fermenta, we do export to the regulated markets. Our plant is inspected by US FDA, our product has a CEP certification. Quality and safety are the building blocks of Fermenta’s DNA and hence it is always of paramount importance to us.
Needless to mention that we too would like to be aligned with our Government’s ‘Pharma Vision 2020’, which aims to make India a global leader in end-to-end drug manufacturing. Joining hands with PIC/S will take us closer to this goal.
– Prashant Nagre, CEO, Fermenta Biotech
While the pharma companies, already complying with USFDA, UKMHRA and EU Standards, can comply with PIC/S norms, a large number of SMEs are not yet ready. Many of them are Schedule M compliant and need to graduate themselves to WHO-GMP and PIC/S levels.
The Pharma SMEs in India require funds for upgradation of their facility and equipment. We have sought Technical Upgradation fund from the government to help the SMEs graduate to WHO-GMP levels. The SMEs also require training on quality management systems, quality risk management, product quality review, stability studies and change control.
IDMA is planning to conduct training programmes all over India with the support of Department of Pharmaceuticals for SMEs in this regard. It may take three to five years for all SMEs to come to a level of WHO-GMP and PIC/S, provided they have given timely financial assistance and training. It may take another three to five years, to be accepted as a Member Country of PIC/S.
– S V Veerramani, President, Indian Drug Manufacturers’ Association (IDMA)
Joining the PIC/S forum will help the Indian pharma industry improve quality standards. It will help boost exports and strengthen India’s credentials as amongst the best quality manufacturers of pharmaceuticals globally. It will help pharma companies to facilitate networking and confidence-building, to promote the quality of inspections and quality assurance of inspectorates, to coordinate training of inspectors, to provide a framework for the exchange of information and experience in GMP, and to enhance global harmonisation of GMP.
It is going to impact Indian export growth as more and more countries are now looking for PIC/S compliance. India should join the league at the earliest. There is a need to harmonise GMP inspection standards through the training of inspectors in developing countries to ascertain the quality of starting materials and manufactured pharmaceutical products and the PIC/S provides a platform for activities in this area.
Original goal
- PIC/S Goal “To lead the international development, implementation and maintenance of harmonised GMP standards and quality systems if inspectorates in the field of medicinal products”.
- Harmonised GMP requirements
- Mutual recognition of inspections
- Uniform inspection systems
- Training of Inspectors
PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry mutual confidence.
The PIC/S has been set up in order to provide, in the interest of public health, for the co-operation between pharma inspectorates with a view to
- fostering and maintaining mutual confidence;
- promoting quality management system for inspectorates and best practices and standards in the field of inspections; and
- contributing to global harmonisation of standards of good manufacturing practice (GMP) for medicinal products
The Indian regulators should work towards making India a member of PIC/S within the agreed timeframe
- Developing and promoting harmonised GMP standards and guidance documents.
- Training competent authorities, in particular GMP inspectors.
- Assessing (and reassessing) GMP Inspectorates.
- Facilitating the co-operation and networking for competent authorities and international organisations.
Benefits of PIC/S Membership
- Accession forced improvements – i.e. discipline
- Cost saving – import control mechanism
- Facilitated exports of medicines
- Training (seminars, joint inspections, etc.)
- Involvement with developing international GMPs
- Facilitated MRA with EC
- Networking and personal contacts
– Rajashri Ojha Survase, Managing Director, Raaj Global Pharma Regulatory Affairs Consultants (GPRAC)
Indian companies are not ready for PIC/S. Being ready for PIC/S means 100 per cent manufacturing units in India should follow GMP standards as a matter of regular practice and not only for audit.
The concept of quality should percolate in every brain cell of all working in this industry. According to me, it is the mind set which needs a complete paradigm shift. It is true that the moment the companies resist, it will surely prove that they manufacture drugs of sub-standard quality.
Rather, I would like to emphasis that foreign regulators already believe that we are compromising a lot on quality. Indian pharma companies’ action plan should be to invest in quality facility, quality machines, quality training and quality products in case it is made compulsory to join PIC/S.
If business risk needs to be taken then it should be in making the mindset change and think like a regulated country. Once that is in place we can achieve it. We are talking of globalisation, it means uniformity across the world. In such a case, why will anyone allow disparity in quality standards in medicines from India?
There is absolutely no alternative to PIC/S or to follow GMP as in regulated markets. There are some countries, which are categorised as non-regulated markets. In the next four to five years, I can see harmonisation of quality systems worldwide and there will be nothing like non-regulated market.
Non-regulated is, in other terms is considered quality compromised, and no one would like to take sub-standard drugs in their country.
– Deepali Chile, CEO, Brassica Pharma
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