India’s deficient drug regulation system is being examined now since after sixty-nine children in Gambia lost their lives after taking cough syrups that were manufactured by a Haryana-based pharmaceutical firm.
And this is not the only the first time that a bad recordkeeping coupled with the passing of substandard medicines with no accurate quality checks has raised health concerns for people. India is one of the largest countries in terms of manufacturing medicine in the huge quantity. However, spurious as well as counterfeit medicines are being released into the market. It is apparent that pharmaceutical companies are familiar to exploiting lax quality testing regulations, a disjointed system of licensing authorities, gaps in the implementation of drug regulatory statutes & subpar supply and procurement systems.
Over the past few years, adulterated & falsified drugs have got several media attention & led to a few public debates. However, substandard drugs being manufactured on a larger scale, also result in deaths of infants and children, that have not been able to make it to major news. It is not the 1st-time drugs have not passed the quality tests and resulted to the loss of lives in the country. Several governments across the globe impose regulations on pharmaceutical firms with an aim to protect their citizens from the harmful effects of pharmaceutical drugs. These regulations most of the time extend the process for discovering newer pharmaceuticals to the market.
The FDA makes sure that new drugs are tested rigorously in order to ensure safety as well as efficacy, for minimizing side effects. Therefore, as a consequence of this testing, several new drugs are being researched & investigated for ten years prior to being brought to market & are made readily available to the consumers. Particularly, drugs should go through human trials that are intended to find out the potential side effects as well as accurately gauge treatment efficacy. If a new drug doesn’t have effectiveness or triggers side effects that are not desirable, during any point in the multi-iterative testing phase, the enterprise would elect to conduct laboratory research further in order to achieve superior results. As this can be a pricey process, firms most of the time consider if it makes fiscal sense to continue their attempts for achieving the desirable results, or if they should be shifting their resources somewhere else.
The significance of R&D in pharmaceutical sector Throughout the R&D process, pharmaceutical firms should be cultivating reliable financing sources. And this typically originates from loans, investments/revenue from the sale of products which have been approved, already. Also, long-established drug producing firms with profitable product lines never depend on outside inventors, like that of smaller startups drug companies, who most often raise venture capital funds in order to bankroll their efforts. In addition to the aforementioned process, Mergers & acquisitions
are also frequent occurrences in the pharmaceutical landscape and this activity can benefit greatly both the smaller as well as newer firms, as well as larger, more established corporations. While big firms may take hold of opportunities with an aim to acquire profitable new products, small firms would enjoy financial boosts & marketing expertise which the larger partners can provide. Owing to high regulatory expenses, firms should be possessing a strong incentive for rendering support to only the most promising drugs, as a rule. However, Mergers & Acquisitions often only occur after a new drug has displayed a strong potential for success in trials.
Orphan Drugs While a few of the drugs benefit from additional government incentives, the orphan drugs get special consideration from the Food & Drugs Administration that enables pharmaceutical firms in developing treatments for rare diseases and the incentives may comprise quicker approval time, along with financial assistance. Moreover, organizations are most of the time led to charge substantially higher prices for orphan drugs. This helps in gaining greater profitability rather than what would be possible without any government intervention. As a result, the development of orphan drugs conventionally expands at higher rates than the traditional pharmaceuticals developments.
IoT’s role in helping pharma firms to meet rising stringent regulations “The digital space and recent technology development in the world with the advancement of technologies, data and information become the fuel of the economy. The data and information are used for the purpose of the predictive analysis and decision-making,” says Sunil K Sonare, General Manager and Head - IT, Sadbhav Engineering Limited. The contamination of pharmaceuticals is highly dangerous since it reduces the effectiveness of the medication, to a greater extent, which makes the consistent end-to-end monitoring of pharmaceuticals highly crucial in maintaining the growing revenue levels of the industry.
Some of the countries code of good wholesaling practice for medicine shows the guidelines which should be followed by all 3rd-party associations that include suppliers while exporting & importing pharma goods. And the guideline presents the stringent pharmaceutical traceability that should be there during the supply chain phase. One such company that offers digital asset tracking solution is Adopt ideations.
The company’s product - KELVIN Pro, renders a solution for meeting the strict regulations that are being faced by the pharma sector. This IoT-enabled asset tracker provides a holistic solution to organizations in tracking their end-to-end visibility, as well as monitoring of consignments. Therefore, by utilizing the Internet of Things technology, KELVIN Pro facilitates in monitoring location, light, temperature as well as shock that sends near real-time alerts if there are violations of set parameters.
In a nutshell On the whole, government regulation of the drug industry has led to longer, and highly expensive product development tasks which favor treatments for rare diseases. All approved drugs have been tested by the Food & Drugs Administration rigorously with an aim to protect consumers from either harmful or ineffective treatments.
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