Drug safety and monitoring is a continuous scientific process which is consist of detection, assessment, perception and prevention of Adverse Drug Reaction (ADR). The process is essential to understand the potential benefits of the medicines along with the risks associated with it. We call it a ‘continuous process’ as it starts with drug development and continues till the launched drug/product is available in the market in patient care.
This process has to be prolonged till the life of particular medicine, as many times the side-effects come into the picture in the post-marketing scenario and after the prolonged use of the drug in the population.

Three barriers

Evolving over the decades, drug safety systems (or pharmacovigilance) are making significant progress. However, the challenges are still there which are inevitable and require new thought every time. Some of those common roadblocks are related to patient engagement, informatics, business and lack of globalized approach toward pharmacovigilance. Discussed below are some social, technical and business-related aspects of drug safety issues in India-

1. Social barriers for drug safety-
In my opinion, social barriers which are depressing the drug safety systems are occasionally hard to identify and challenging to nullify. Public belonging to different levels in the society have different pitch of understanding and awareness about drug safety which makes it difficult for organizations and government to resolve the issues. Following are some of those major obstacles-

• Ignorance toward minor side effects– This particular issue is very common and serious at the same time. Because of this, pharmacovigilance systems are not getting prioritized in the society despite of tremendous efforts of government. One of the major reasons behind this is lack of knowledge about the severity of adverse drug reactions and varying mentalities of people. Frequent use of antibiotics and injections is an issue of concern in recent times. Nations are struggling to put light on these issues and find the ways out.
• Medical professionals seemingly lacking experience, up-to-date knowledge and drug information– This is another major issue in the society. This can be complementary to the previous issue as medical professional play crucial role in shaping the reliable healthcare. Inadequate treatment guidelines are passed on through such medical professional. Poor prescribing practices can also be seen.
• Prevalence of counterfeit products and use of traditional medicines (without any knowledge)– This issue is gaining much attention in today’s scenario. Cheap, substandard and spurious drugs in the market used to put the drug safety systems in questionable circumstances. Although, as the research and development is advancing, various government initiatives through regulatory actions are making a big difference between today’s and a decade ago scenario in pharmacovigilance.

Another issue is use of traditional medicines without any fundamental background knowledge. As many alternatives are available in the market at cheaper prices, the public is seemed to be inclined toward them through the word-of-mouth information.

Technical barriers for drug safety–

The gaps between guidelines and law for drug safety is one of the matters of concern for nation like India. Lack of harmonization of guidelines due to presence of different ministries for drug regulation make it hard to coordinate and maintain transparency in the process. Discussed ahead are some of these regulatory issues which require serious attention-

• Ambiguity in licencing mechanisms- In India, there is a thing called as dual licencing mechanism which has emerged as a roadblock for effective implementation of regulatory processes in India. Moreover, transparency in licensing procedures need to be further improved. Lack of better clarity on patentability of pharmaceuticals for which any organisation applies for compulsory licences leads to legal dispute between MNCs and local firms.
• Interpretation issue of GMP guidelines- Inadequate and not correct interpretation of rules and guidelines of drug development in India generate multiple barriers for effective implementation of drug safety programmes. Experts who have very less knowledge about strict legal terminologies in documents such as Schedule M, Drugs and Cosmetics Act, 1940 and, Drugs and Cosmetics Rules, 1945, can’t interpret the things efficiently which result in difference in the assumptions of regulatory officials and drug developer.
• Compliance in clinical trials- Noncompliance of ethically documented clinical trial practices result in unethical practices in clinical trials of drugs in India. This is a product of corruption, poor compliance, low-cost trials and the conniving acts of drug developing company and medical professionals. Such cases are on the rise in the current scenario. Moreover, unavailability of basic facilities and sophisticated instruments lead to unethical clinical practices by producers.
• Issues of pharmaco-negligence- This is one of the factors behind proliferation of substandard and spurious drugs. In India, huge number of patients having malaria and tuberculosis died because of such counterfeit drugs and products. Lack of coordination between centre and state regulatory bodies has resulted into very tough time for pharmacovigilance in India in earlier times.
• Inadequate recall mechanism- In India, it takes about three to four months for laboratory to process through the fraudulent product. During this large timespan, the huge percentage of batch gets consumed in the market. The recall mechanism is unclear and the information of the product recalled are not available in public domain. This makes the situation even more complicated and tough to deal with.

Business-related barriers for drug safety-

Many times, processes at drug producers level/company level are also responsible for the failure of pharmacovigilance programmes in India. Following are some of those issues which need legal consideration-

• Organizational insufficiencies and malpractices- Unavailability of required funds, inadequate and unprofessional staff, etc result in weak organizational functioning. Frustration resulting from extra-working hours and the ignorance arising through it is responsible for poor quality end product.

Many drug producers, manufacturing poor quality products, invade the supply chain of slow-moving products (products which usually have slow turnover rate and likely to be stored into the warehouse for longer timespan) to avoid the detection procedures.

• Unclear third-party agreements- This involves entitling a manufacturer to do the manufacturing on behalf of other party. This entire process is a big question mark owing to the unclear legal liabilities associated with quality of the product rolling in the market through third-party manufacturing.
• Unawareness about handling new technologies- Most of the stakeholders are not technically competent and some of the reasons behind it are affordability and lack of knowledge. Indian stakeholders, many a times, avoid costly and complicated technologies like ‘track and trace technology’ which make their growth less sustainable and such situations result in adoption of cheaper ways of making money, E.g., Counterfliet products.

Change is essential

Social conflicts associated with drug safety require considerable attention in the form of public campaigns for pharmacovigilance and awareness-enhancing initiatives in rural areas. The adverse drug reactions can be minimized to the great extent through such social approaches. Communication is the key to knowledge, government and regulatory bodies should design these initiatives in much comprehensive manner. Such approaches are essential for health professionals as well for the better healthcare outcomes.

Technical issues, particularly regulatory system related issues, are need to be tackled with thorough understanding about the current scenario of pharmacovigilance in the nation. Uniformity in the regulations as well as in the interpretation of the same is mandatory for ‘up to the mark product’. Various technologies used abroad can be utilized in India to achieve efficient licensing mechanism, ethical clinical trials and accelerated recall processes.

Such approaches require active participation of the stakeholders with the dedicated and honest efforts in producing the high-quality pharmaceutical product. Drug safety programmes can be successful only if the data provided by the stakeholders to the regulatory bodies is accurate in all the aspects in order to device the essential policies.

Global approach is mandatory to develop a science-based, patient centric healthcare through high quality products. To strengthen the pharmacovigilance system in the world, regulatory harmonization is the key…

  -Dr. R.B. Smarta
CMD-Interlink
Vice President (HADSA)

About Author:
Dr. R. B. Smarta- Founder and Managing Director of Interlink Marketing Consultancy Pvt. Ltd. Being a thought leader in Pharmaceutical, Nutraceutical and wellness industry, he has been contributing globally through Interlink Consultancy and building business performance of his clients for 36 years. Having a Master’s degree (M.Sc.) in Organic Chemistry in Drugs, MMS in Marketing, PhD in Management, and FRSA (Fellow of Royal Society of Arts) London, he is-perusing his passion of converting science to Business. Besides being a consultant, he has been teaching at IIM, prestigious management institutes, Pharmacy College, Pharmacists Associations, guiding PhD students and written as many as 7 Books on Management, Pharma, Nutra, Foods domain, and many articles in prestigious journals/magazines.