Is affordable also effective? The debate over Jan Aushadhi rages in Kerala

Dr. Arun NM of Palakkad recently encountered a troubling case. A patient came to him with unexpected fluctuations in TSH levels. Concerned, he asked them to bring the medicine they had been taking. What he found was shocking—the patient had been consuming Thyrohelp, a duplicate version of the original Thyronorm, with Gromax Medicare listed as the distributor. Despite being priced the same as the genuine medication, it was not the prescribed drug they actually needed.

Dr. Arun says this is not an isolated incident. Many people turn to Jan Aushadhi pharmacies, trusting them for affordable, government-approved medicines. However, he warns that some unsuspecting patients may end up with duplicate versions of well-known brands, like Thyrohelp, which have no connection to Jan Aushadhi or the original medication they were prescribed.

This wasn’t an isolated case. Dr. Arun has come across similar instances where patients unknowingly ended up with medicines that were not giving effective results.

Case 1: Thyroid shock

Patient A had been managing hypothyroidism for three years with a branded medication was maintaining stable thyroid levels. In July 2023, her TSH was 3.75, well within the controlled range. However, by November 2023, her TSH had skyrocketed to 100, accompanied by fatigue, weight gain, and other hypothyroid symptoms. They assured the doctor that they had been taking their medication regularly but revealed that, for the past three months, they had switched to a Jan Aushadhi version of their usual medicine.

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The doctor advised them to return to the previous brand, maintaining the same dosage. By February 2024, their TSH had dropped drastically to 0.41, suggesting a possible inconsistency in the effectiveness of the medication.

Case 2: "Modi’s Medicine"

Another patient with four years of stable thyroid function came in for a check-up in October 2024, only to find that their TSH had surged to 100. When asked where they were sourcing their medicine, they dismissively referred to it as “Modi’s medicine”, implying they had been purchasing it from Jan Aushadhi outlets. The doctor suggested they return to their previous brand while keeping the dosage unchanged. By January 2025, their TSH had dropped to 0.25, necessitating further dosage adjustments.

Case 3: Diabetes spike

A diabetic patient under this doctor’s care for five years had maintained stable blood sugar levels. Their June 2024 test results showed an HbA1c of 6.4%, FBS (fasting blood sugar) of 71, and PPBS (postprandial blood sugar) of 130. By October 2024, their numbers had drastically worsened, with an HbA1c of 8.4% and PPBS rising to 268. When questioned, they admitted that they had switched to Jan Aushadhi diabetes medications a few months earlier.

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The doctor advised them to return to his previous medication, but to address their financial concerns, one of the drugs was substituted with a different cost-effective brand. By November 2024, their fasting blood sugar improved to 74, but postprandial levels remained elevated at 234, indicating that while some Jan Aushadhi medicines might work, their impact may vary from person to person.

Case 4: A measured success

Not all experiences with Jan Aushadhi medicines have been negative. A diabetic patient of 10 years, who first consulted this doctor in June 2024, had dangerously high blood sugar levels (FBS 221, PPBS 354, HbA1c 10.5%). He had been using Jan Aushadhi medicines and had brought them to the consultation. Instead of switching their medication, the doctor prescribed the same drugs from a branded company, while also advising lifestyle changes. By July 2024, their FBS had dropped to 141 and PPBS to 210. With a minor dosage adjustment, their September 2024 test results showed further improvement (HbA1c 7.8%), proving that some patients can effectively manage their condition with Jan Aushadhi medicines if used correctly.

“While these cases are not definitive proof against Jan Aushadhi medicines, they highlight key concerns regarding potency, consistency, and individual response to generic drugs. Many patients have successfully controlled their blood sugar, cholesterol, and blood pressure with these medicines. However, thyroid regulation appears to be the most challenging, followed by diabetes management” Dr. Arun told The Federal.

Another critical issue is dosage adjustments when switching back to branded drugs. Patients who control their blood sugar with Jan Aushadhi medicines may experience low blood sugar (hypoglycemia) if they return to a brand-name version without modifying the dosage.

When asked whether patients should opt for Jan Aushadhi medicines, the doctor provides a measured response:

"You can try them, but if your condition does not improve, before increasing the dosage, first test the same medicine from a standard pharmacy and compare the results."

For patients with long-term diabetes (over 10 years), severe hypertension, heart disease, strokes, or kidney issues, the doctor strongly advises against experimenting with medication changes.

The Jan Aushadhi Scheme, initially launched in 2008 by the UPA government with the aim of providing affordable generic medicines, has undergone notable transformations under the NDA government led by Narendra Modi. While the scheme's original goal was to ensure essential drugs were accessible to those economically disadvantaged, critics argue that the NDA government has strategically rebranded and repackaged the initiative, primarily to highlight the ruling party's image.

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Upon the BJP's ascent to power, the programme was initially renamed the Pradhan Mantri Jan Aushadhi Yojana. Subsequently, in November 2016, it underwent another renaming to the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana—a move seen by some as an attempt to overtly emphasize the abbreviation 'BJP' within the scheme’s title. While government-run Jan Aushadhi stores prominently feature Modi’s image on large billboards, there has been limited expansion in their reach, with the total number of outlets hovering just above 10,500.

Furthermore, persistent issues within the supply chain compromise the consistent availability of medicines in Jan Aushadhi outlets. Some consumers also express concerns about the quality and composition of generic medicines compared to branded drugs, a sentiment often echoed by doctors who perceive branded medicines as superior.

Some observers suggest that commercial interests are at play, with branded drug manufacturers fearing that the widespread adoption of generic substitutes would undermine their market share. This perspective suggests that efforts to promote generic medicines through Jan Aushadhi stores may face resistance from powerful pharmaceutical companies seeking to protect their profits.

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Discussions surrounding doubts about Jan Aushadhi medications are not new. Complaints have been raised since the scheme's inception. Kerala is among the states with the highest number of outlets under this Union government initiative, providing medicines to a large number of beneficiaries.

A couple of weeks ago in Kerala, a social media post by an affected individual reignited discussions about the quality of medicines distributed through Jan Aushadhi outlets. Interestingly, almost all of these discussions stemmed from empirical data or anecdotal evidence.

On the other hand, a simple search on the internet reveals numerous studies that categorically state Jan Aushadhi generic medicines are effective for the aforementioned ailments. Several research papers have examined the efficacy and quality of these medicines, comparing them with well-known branded counterparts. These studies consistently affirm that Jan Aushadhi drugs meet the required standards and deliver comparable therapeutic benefits, reinforcing the credibility of the government’s initiative to provide affordable healthcare.

A study published in the Journal of the Scientific Society in 2022 examined the effectiveness of Jan Aushadhi generic medicines used for hypertension. The findings confirmed that these medications were effective in managing blood pressure, reinforcing the credibility of generic alternatives available through the government’s scheme.

In 2023, another study published in the International Journal of Pharmaceutical Sciences compared the Metformin available at Jan Aushadhi outlets with seven other branded versions commonly found in Hyderabad. The research concluded that the generic Metformin offered at Jan Aushadhi exhibited efficacy equivalent to its branded counterparts, dispelling concerns about its potency.

A similar study conducted by researchers Panchal, Nirav; Tailor, Pratik; Mishra, Ashish; and Shah, Shailesh in 2019 focused on the quality control testing of Jan Aushadhi medicines. Their comparative analysis of Metformin tablets available across different brands in India reaffirmed that Jan Aushadhi's version met the same quality standards as the more expensive branded alternatives.

Further supporting these findings, a 2011 study published in the International Journal of Pharmacy and Pharmacological Science evaluated multiple Jan Aushadhi generic medicines, including Alprazolam, Cetirizine, Ciprofloxacin, and Fluoxetine. The study found that these medicines were on par with their branded counterparts in terms of quality and effectiveness, challenging the perception that generic drugs are inferior.

Most recently, in 2024, a study published in the Saudi Pharmaceutical Journal examined the quality and efficacy of commonly prescribed antihypertensive medications such as Irbesartan, Valsartan, Losartan Potassium, Olmesartan Medoxomil, and Telmisartan. By comparing the Jan Aushadhi versions with well-known branded equivalents, the research confirmed that the generic medicines maintained the same quality standards, further strengthening the case for affordable, government-supplied pharmaceuticals.

“Quality control in India, when compared to the West, is relatively weaker. However, this issue is not limited to Jan Aushadhi alone. Despite this, India’s pharmaceutical industry remains strong, especially in comparison to many other developing nations. The country is one of the largest drug exporters in the world, supplying a significant portion of generic medicines to the UK, the USA, and other European countries—regions known for their stringent Good Manufacturing Practices (GMP) regulations. Many of the same pharmaceutical companies that meet these high international standards also supply medicines to Jan Aushadhi,” opines Dr K P Aravindan a senior Pathologist based in Kozhikode.

“Despite this, some doctors and chemists oppose Jan Aushadhi medicines. Interestingly, the very pharmaceutical companies these doctors endorse are the same ones manufacturing generic drugs, including those distributed through Jan Aushadhi. India is one of the world's largest producers of generic medicines, a position strengthened by its earlier patent laws, which allowed only process patents. This gave Indian manufacturers a significant advantage, enabling them to develop generics more easily and establish an early lead in the global market,” adds Dr Aravindan who had been the President of Kerala Sastra Sahitya Parishad, the people’s science movement.

The debate over whether doctors should prescribe generic or branded medicines is a long-standing one. While generic medicines are more affordable and chemically equivalent to their branded counterparts, many doctors and medical associations, including the Indian Medical Association (IMA), have raised concerns about quality control, efficacy, and the reliability of generics available in the market.

Proponents of generic prescriptions argue that they make essential medicines accessible to a larger section of society, reducing healthcare costs significantly. On the other hand, those advocating for branded medicines highlight the stringent quality checks and consistent performance associated with established pharmaceutical brands.

At the core of the debate is the question: Who should have the authority to choose the brand—the doctor, the pharmacist, or the patient? While some believe that empowering pharmacists to make the selection ensures cost-effective options, others argue that doctors, with their deeper understanding of the patient’s medical condition, should have the final say to ensure treatment efficacy.

“When it comes to generic medicines, brand names should not be used. For example, if a medicine is labelled Acetaminophen, it refers to Paracetamol. In government hospitals, this does not pose an issue, as they supply medicines from their own stock, which includes specific brands. However, in medical stores, the question arises—who chooses the brand? Ideally, the best scenario is for the patient to have the freedom to select the most suitable brand. But given the healthcare landscape in our country, this may not always be feasible,” says Dr Jinesh PS an Australia based surgeon from Kerala.

“If the patient cannot make an informed choice, the question remains: should the selection be made by the doctor or the pharmacist? In such situations, it is preferable for the doctor to decide. This is because medical stores do not track whether a patient’s condition improves or not—there is no audit system in place for such outcomes,” adds Dr. Jinesh.

The scrutiny of Jan Aushadhi medicines in Kerala is not without reason. The skepticism surrounding them may not solely stem from distrust of big pharmaceutical companies but also from political factors. The overt politicisation of Jan Aushadhi outlets, the franchise selection process, and the involvement of BJP leaders have fueled suspicion among political activists in the state. This has led to concerns that go beyond the quality and effectiveness of the medicines, intertwining healthcare accessibility with political affiliations and power dynamics.

“It’s no secret that the project underwent a name change, making it closely resemble a political party. Those with connections to BJP leaders have secured franchise rights—something widely known," a senior government official told The Federal.

On the other hand, grassroots politicians are hesitant to oppose the project solely based on empirical data findings.

“This is one of the rare Union government initiatives that genuinely benefits common people. Thousands rely on it, and the price difference is significant. We are also pushing for cancer drugs to be included in the scheme. In such a scenario, we cannot make unsubstantiated allegations. Let’s test the drugs, and if we find serious anomalies, we will take it up then," a CPI(M)-affiliated union leader in the health department told The Federal.

Dr. Arun NM had filed a complaint regarding the quality of certain drugs, but since the medicines from that batch had already been sold out, they couldn’t be tested. Instead, another sample was examined as part of a statutory requirement, and the authorities reported no issues. Last month, he filed another complaint, and this time, some medicines are still available. It remains to be seen whether any action will be taken.