We Indians are inherently cautious and thrifty. We cannot be told that one can save money by spending money. Once upon a time in India our strength, if it can be called that, was cheap labour. Now that strength has become our biggest weakness.
In the pharma industry, which is unique from most others, and particularly in pharma manufacturing, which is subjected to audits by regulatory authorities, both domestic and foreign, most of the errors are due to human failures. Machines do fail, but predictive maintenance can keep a machine trouble free. Such a regime is not possible for a human being.
Fortunately or unfortunately the Indian pharma industry is split between those that export and those that make solely for the domestic market. Some manufacturers who are in both markets segregate their manufacturing facilities so that the ones for export are not used for domestic production.
Regulatory requirements have grown seemingly exponentially. After all pharma products made anywhere are ultimately for consumption by a human and will, therefore, impact directly on our well being. It is only right that the product is safe and within acceptable risk, throughout its life cycle. The US FDA considers this so necessary that it has a special Office of Lifecycle Drug Products. However, the pharma landscape is ever-changing, and drug companies are under intense pressure to improve product pipelines, accelerate time to market, and improve margins everywhere in the world.
It has been estimated that the average cost of bringing a new drug to market is $2.6 billion, according to a 2014 report published by Tufts Center for the Study of Drug Development. This is a rise of 145%, adjusted for inflation, compared to just a decade earlier and is driven in part by the increasing complexity of clinical trials. Patient compliance becomes a huge issue. That means each patient who drops out of a trial can have a significant impact not only on development costs, by lengthening the time frame of a study, but also on the potential revenue generation a new therapy can deliver. As a result, the biopharmaceutical industry will continue to explore new and better clinical trial processes to encourage patient recruitment and retention – such as the Direct-to-Patient (DTP) distribution model.
Outsourcing in the pharma industry, like in other industry, became a trend too, not just in manufacturing but also of services. This saw an entry of IT specialists who developed software for various requirements. One of the most successful and sought-after programs has been ERP software, originally developed by SAP, Germany.
The pharma industry took to ERP like a duck to water because a whole host of consultants could tailor-make it specifically for the bits required by the particular buyer and exclude areas they did not want it to cover. SAPs original software did not permit individual customizations.
Pharma equipment manufacturers were quick to learn and did not want to be left behind. There is a whole host of equipment designed and manufactured to be ERP compatible. All these, in turn, have, in gradual increments, surreptitiously or consciously, allowed the pharma manufacturer to cut down labour costs even further and improve compliance.
Pharmaceutical companies, with global supply chains, have to grapple with a host of different issues. If you are a marketer distributing your products in the US as well as EU, even a simple thing like stamping the Expiry Date becomes complex. In the US the date is stamped by Year/Month/Day whereas in Europe, as is in India it is Day/Month/Year. Besides this, a pharma product pack needs a definite identity regarding place of manufacture, batch details, etc. To add to this, in tropical countries the storage requirements are more stringent, and this has to be specified on the product packaging.
Today the trend is to capture end-to-end data, from input to output and sales or serialization of every manufacture, enabling Track & Trace. US FDA has, in the meanwhile, postponed by another year the first phase of DSCSA (Drug Supply Chain Security Act) to enable companies to gear up to these requirements and refine their serialization process.
Serialization will remain a hot topic in 2018. Supply Chain connectivity will also be a huge challenge. Terms like Block Chain and Cloud Computing being bandied about with reference to Bitcoin and Data Storage will become realities in the pharma industries for SCM (supply chain management) and for becoming a Smart Factory.
Regulatory authorities, particularly the US FDA are also very concerned about adverse reactions to newly launched drugs, or even drugs that are out of patent and generic products have taken over. The US FDA recently launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. According to FDA Commissioner Scott Gottlieb, M.D, tools like FAERS are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA.
The other trend, inevitable indeed with online shopping surge, is the growth of internet pharmacies. This brings the risk of counterfeit drugs, another a huge challenge that can be overcome by Block Chain type technology and use of cloud computing.