Quality of Generic Medicines: A big challenge for the Pharmaceutical Industry in India

The superiorities of branded medicines versus generic medicines have enticed fervent controversy among physicians, medical consultants, pharmaceutical professionals, media, and healthcare activists.

It is crucial to apprehend the contrasts between branded drugs and generics since the nuance is quite multifarious in the Indian context. As per the USFDA- United States Food and Drug Administration, “ The approval for a generic drug can only be attained after it has fulfilled the rigorous standards ascertained by the FDA with respect to the disposition, vitality, quality, purity, and efficacy. All generic sites including- manufacturing, packaging, and experimenting sites must uphold the exact integrity and quality standards as those of brand-name drugs. The generic drug manufacturer must substantiate the drugs' bioequivalence to the brand name drug. For instance, after the patient consumes the generic drug, the proportion of the drug in the bloodstream is assessed. If the amount of the drug in the bloodstream is the exact as the amounts established when the brand name drug is consumed, the generic drug will function the same way.”

As per the top pharma franchise company in India, It is apparent that the only distinction between a branded drug and a generic one is that branded drugs are relatively expensive, while generics are far more economical and are sold by barely the pharmaceutical salt label. This is valid for brand-name drugs and generics in maximum developed countries.

Generally, brand names are bestowed to researched, experimented and patented trailblazer drugs. After the deadline of the patent period, distinct companies launch the generic drugs of the originator drug with just the pharmaceutical salt label at a highly reduced price. So, the only disparity between a brand-name medicine and its generic edition is the price.

Whilst Generic drugs are inexpensive, they are also backed by the government, which authorises doctors to prescribe them. The concern lies in the decent or poor quality of the drugs that are produced and sold in India.

It is reckoned that barely one per cent of the generic medications go through quality tests comparable to those drilled in the US. This can result in a terrible situation in India where the impediment of diseases might heighten due to counterfeited and sham drugs.

The best pcd pharma company in India explains, The hardship in India is not about costly brand name drugs versus inexpensive generics, as in the West, but is of quality medicines versus suspect quality medicines.

Branded generic drugs produced by the generic medicine pcd companies are also the generics but with a brand name, along with excellence in terms of quality and integrity confirmation from prominent companies like Cipla, Dr Reddy’s, or Sun Pharma. Physicians have to appear to believe these companies and their varieties over time. Indian pharma squad numbering almost one million medical representatives have done a decent job of assembling this trust in their companies and brands. It is clearly not possible for physicians to disseminate this belief to generics which are manufactured by anonymous companies. And in maximum cases, the generics are sold with a brand name – the only distinction being that these brand names are not widely endorsed or promoted. So, if a specialist specifies a drug with only the pharmaceutical salt label, then at all odds, the chemist will disperse other branded generic or generic drugs of skeptical quality.

PCD pharma franchise generic medicine Company, Steris Pharma says, The entire dilemma of inexpensive generics is based on the inference of measurable and enforceable certainty about integrity through bioequivalence examinations and other globally decreed parameters. The lack of a worldwide standard drug administrative mechanism like the USFDA, Indian physicians have to count on the prestige of organizations like Cipla, and Sun who have illustrated their responsibility to integrity over time and come to be trusted names in the sights of medical specialists and patients.

Also, Indian branded generic corporations have been resourceful in terms of drug delivery networks to refine absorption and curtail side effects, thereby enhancing the efficacy of the drug. This novel drug delivery system (NDDS) drugs are obtainable in all classifications of drugs from most familiar mouth dissolving pain-killers for immediate results to complicated diabetes drugs that are circulated into the blood in a smooth stream to assure promising blood-sugar supervision with smaller chances of hyperglycemia – one of the harmful complications of consuming diabetes medications.

Shoddy drugs have been a formidable issue for India over the last few decades. A few years back, the central drug standard control organization recognized nearly 4.5% of all generic medicines in the domestic market to be substandard and lousy. The issue commences with the inadequacy of integrity and quality examination facilities in the US there is a draconian quality supervision procedure and systematic quality check facilities in place but India has a varied story to tell. Unbridled corruption makes it a cinch to attain a drug licence through bureaucratic or political alliances.

Additionally, drug control protocols in India experience a lack of resources and workforce extensive corruption within the structure makes matters terrible.

Another problem is with the counterfeit drug sellers who supervise at the retail level and procure unlawful drugs from ambiguous suppliers. Sham agents sell spurious drugs illegally expanding the name of a pharmaceutical company that stays completely oblivious of the occurrence while combatting this issue is beyond the scope of the pharmaceutical company. It is critical that it is stopped forthwith since it wrecks the stature of the country. Till now numerous reputed pharmaceutical companies have found themselves landed in heeding anger over bogus drug disgraces of which they were not a part.

The method of issuing guidelines and implementing them could eat up years and decades, going on prior experience. The government must sit down with all stakeholders to talk over the matter and roll out a duration-bound blueprint to make generic prescriptions compulsory over the following three to five years. This will give the essential time required by all stakeholders from industry to physicians, dealers, and patients to get used to the fresh system. For example, the government can roll out a generics-only plan for one group of drugs like anesthetics (pain-killers) and see how it functions and comprehend from it and progressively rolls it out for all additional groups of drugs.