SSI drug units in globalised economy
Small scale industrial units can function as ancillary units for big players, and get the support of superior technological inputs and financial back-up from them, says G B Sastry
If a person from SSI pharmaceutical unit was to have gone in to a ‘Rip Van Winkilian sleep’ in the early ’90s, and woke up now, he would be surprised, shocked and amazed by the transformation that has taken place in the working of pharma units.
Work practice requirements of pharma industry started as GMP then added a prefix, letter ‘C,’ this innocent looking letter when tagged to GMP kept pharma working on a treadmill of constant change.
While the industry is still in the process of acquainting itself with GMP, adding further woes came cGMP along with GLP, GCP and what not. All the above developments/changes took place within a short span of over a decade.
Absorbing these many changes technically and affording the costs commercially is a daunting task for Indian drug SSI units. To the industry’s credit, it gave a good account of itself in this regard to a large extent. The metomorphical change brought into all aspects of Indian pharma working has been revolutionary. None of the changes are indigenous, they are transplanted almost overnight.
With the ‘Damocles Sword’ called implementation of revised Schedule M hanging over their head; SSI pharma units are mortally worried about their survival now.
Although implementation of revised Schedule M has been differed for a year, with a tacit understanding in diluting certain aspects like setting up of mandatory air handling units, area requirements for various activities, analytical requirements like unaffordable HPLCs etc no official confirmation has been issued till date.
Even with truncated revised Schedule M requirements, ability to invest on the part of SSIs is a big question. Almost all of medium scale pharma units numbering around 3000 view this as a threat to their very existence.
As the industry began entering the global arena to sell its ware, unwittingly or otherwise, it started donning the role of Sita from the epic Ramayan.
It is not that industry is revered as the ‘Sita Mata’ by buyers, simili is confined only in being suspected time and again and for proving credentials by jumping into fire called cGMP (revised) norms again and again. Today, it is not sufficient if one is a good pharma manufacturer, one has to demonstrate time and again, that goodness, in word and deed. Like the short life-cycle of pharma products, its facility standards and system standards, requirements, are all coming with a very short life-span. In the sense they are getting revised at an alarming pace, both as statutes and as perceptions of all those donning the role of auditor/inspector.
In many cases, the life span is shorter than the time required to adopt/create or whatever is required to be done.
With such short ‘expiry dates’ and huge investment demands, SSI units who looked at drug-making all these years as low investment, high margin activity are unable to reconcile themselves to changing realities of low margin high investment technology driven style of working.
Let us take a cursory round of shop floor and see what changes are taking place on the facility front. Wood became an untouchable (trees/forests must be happy!) all costly teak wood doors, veenered flush doors (fashion statements of yesteryears) all removed overnight, sent to scrap yards.
Aluminium closely followed by powder coated metal doors and ultimately pharma industries blue blooded heart-throb, ‘stain less steel’ doors view panels have come to stay. Everything that goes in to a pharma unit started having a prefix GMP compliant. This prefix makes anything a VVIP! Now, everywhere in the industry we see equipment being replaced with stainless steel or stainless steel cladded camoflaging all non-SS components. The trend has gone so deep that even furniture is not allowed to be made of any other material except SS.
But it should not be forgotten that properly surface coated steel has the capability to do what a stainless steel can do. One good development is the attention being paid to ancillary activities like utilities etc. Most of the facilities are bringing the conditions of ancillary services as nearer to core area as practicable.
Human error has been systematically reduced by adopting more and more automatic operations, computerised surveillance of machine performance. Today’s facility leaves little chance for unfilled blister going out of a packing line with NFDs cameras keeping a close watch. and rejecting on line what is not conforming to requirement.
Autocoaters complete the target quantity coating in the presence of de-humidified hot air, exhaust generated dust is filtered, then scrubbed and let out. These autocoaters give us considerable quantity of output, with consistent quality, a clean working environment is ensured.
Gone are the days of FBD operations in open areas. Now most of the units adopt the best of climatic conditions they can think of. Air is pre-filtered, refiltered through filters of 20 micron rating to absolute Hepa filters of 99.99 per cent efficiency. Working in open given way to air-conditioned rooms, then they yielded place to class 1,00,000 to class 100 quality filtered, dehumidified and cooled air as per requirements.
Water is treated, purified looped in state-of-the-art systems adopting triclover fittings, arbital welding techniques and many more. After talking about all this outward sophisticacy, if we take a peep in to the heart, one can see not much of change in basic attitudes, approaches and thinking of the industry.
Attitude of compliance on paper, defiance in practice continues to plague our working and image. This slurried image is responsible for prejudiced viewing of our industries working, resulting in many more draconian like compliance requirements coming up every day.
Quality to be integral to production, is yet to brew into system. Somehow complete the job is giving way to somehow quality of output. This has to be corrected. No amount of shining and glittering facades we create can match; time-tested, honest and no-nonsense way of adherence to quality in working.
Shop floor activity is viewing all the thrust on documentation and written down procedure as a drag on the smooth and timely flow of work. Many look at it all as questioning their competence and time tested way of working. This attitude is one of the many causes for ‘compliance on paper, deviation in working.’
Creating adequate awareness, constant training/upgradation inputs will help reduce impact of this attitude. In today’s structured working insisted by documentation and procedures, the sense of pride and belongingness one feels in working is slowly being eroded.
Course content and syllabus of study for people who enter pharmaceutical industry must be recast to suit the needs of this vibrant field of socio-economic relevance. To this end better industry, acedamic feternity interaction will be a good beginning.
Like house surgency for doctors, one year or six months of compulsory intern ship for pharmacy graduates must be given a serious thought.
Inducting people of necessary professional qualification at entry level is good for creating young dynamic adoptive pool of talent for industries sustainable growth.
Most of the SSI pharma units are to face their auditors (both buyer’s and statutory) with meagre financial and knowhow strength at their disposal.
The above inadequacy is making them suffer the fear of unknown (in terms of requirements) and fear of impending unavoidable and unaffordable investment requirements (in terms of facility upgradation costs).
For overcoming the above two problems, sympathetic and objective understanding of government and regulatory agencies on one hand and professional, pro active role of industry and trade associations on the other hand is necessary.
In today’s dynamic world no section of society can afford to remain static, Growth is the order of the day if one is not growing it implies one is decaying. Keeping the above in mind, SSI should start thinking big, should think of coming out of the protactive cocoon of SSI. This has to be achieved by growing big on their own, or by M&A or anything that fits the bill, to achieve the goal of surviving by growing.
Allowing drug making by inadequately equipped SSI sector, in its present state, looks to be not a good thing either for the industry or for the society, it intends to serve.
With all the limitations, an SSI operator will always be seeking concessions and compromises and denies society the advantage of technological growth, and economies of scale. In knowledge-based industries like pharma, real contribution, and growth will be through constant R&D.
Because of all its inherent limitations SSI’s will not be able to cope with the requirements dynamic sector like pharma, where products, processes, requirements are all in a state of constant change always.
Other alternate for SSIs will be to become ancillary units for big players, and thus, go on getting the support of superior technological inputs and financial back up from them, that way only SSIs can play an useful role in this field and carve a niche for them.
In these days of targeted delivery of micronised high efficiency drugs, any small mistake, inadequacy in quality standards in production at any stage of activity will make the drug do harm than good. Today’s drugs are aimed to act at supersonic speed and precession, asking a ‘single seater’ pilot to pilot a supersonic jet is just not right. Same way allowing drug making in compromised manufacturing practices is not at all good.
Pharma SSIs will be successfully adopting themselves to changes and continue to play a meaningful role in future also by redefining their goals, objectives after honest assessment of their strengths and weaknesses vis-a-vis the task ahead of them.
G B Sastry, B 17 Gayathri Society, Near overbridge, dharmapur road, Abrama ; Valsad. 396002. Gujarat. E mail: firstname.lastname@example.org