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 In order to boost pharmaceutical compliance and ensure drug quality of impeccable standards, the Maharashtra Food and Drug Administration (FDA) has initiated a massive crackdown replete with license revocations, seizures and legal actions. The initiatives include upgrading manpower and installing sophisticated instruments in labs for ensuring that the drug regulatory system is equipped to handle illicit drug trade and counterfeit medicines on a war- footing.
The Maharashtra FDA commissioner Abhimanyu Kale offers an insight into the initiatives taken by the state regulator in an exclusive interview with Shardul Nautiyal.
What have been the initiatives of the state regulator in enhancing compliance to norms?
Bringing in advancements in lab testing and method of analysis (MoA) is on high priority of the state drug regulator towards enhancing compliance to norms. High- end testing tools and methods like HPLC, IR, UV and Mass Spectroscopy have been deployed for effective testing of medicinal products towards patient safety.
A new drug testing lab in Pune for timely analysis of drug samples in the state is being upgraded and the manpower today currently stands at 82 plus staff with a total of 200 sanctioned posts. As of today, Mumbai tests 4,000 samples, Aurangabad tests 1,000 samples and Nagpur tests 500 to 600 samples on an annual basis.
All the three labs in Mumbai, Aurangabad and Nagpur are also being strengthened as part of boosting the drug regulatory mechanism in the state through a Centrally Sponsored Scheme (CSS) worth Rs. 136 crore with financial support from the State government. As per the government plan, the Central and state governments will allocate funds in the ratio of 60:40 to strengthen the drug regulatory infrastructure in the state of Maharashtra.
What are the actions taken by Maharashtra FDA to tackle illicit drug trade?
The Maharashtra FDA has taken the decisive move to tackle illicit drug trade in the wake of an exhaustive series of 6,779 inspections carried out by the state drug regulator across the value chain.
The comprehensive inspections laid bare a spectrum of non-compliance issues plaguing the pharmaceutical drug supply chain, ranging from the absence of qualified pharmacists to the improper storage of medicines and the neglect of maintaining accurate sale and purchase records. Responding resolutely, the Maharashtra FDA has suspended 892 retail licenses and 1,033 wholesale licenses.
During the investigative period from April to October, 2023, the Maharashtra FDA orchestrated 53 targeted raids, culminating in the confiscation of pharmaceuticals valued Rs. 2.85 crore within the clandestine drug supply chain. Significantly, 28 FIRs have been filed, addressing violations pertaining to the peddling of spurious drugs and the unauthorized sale of prescription medications.
What has been the outcome of the crackdown on the clandestine activities of the drug peddlers and offenders?
The regulatory crackdown has not only resulted in more than 30 arrests but has also seen the initiation of 3,102 prosecutions against individuals involved in the illicit trade of spurious drugs. Simultaneously, quality control measures have been heightened, with approximately 120 samples declared as not meeting standard quality out of the 3,200 samples subjected to scrutiny by state drug controllers (SDCs).
This expansive crackdown by the Maharashtra FDA underscores its commitment to upholding pharmaceutical compliance, safeguarding public health, and fortifying the integrity of the pharmaceutical supply chain in the state.
What are the challenges faced by the Maharashtra FDA and the way ahead?
In recognition of the need for reinforced compliance measures, the Maharashtra FDA is actively augmenting its workforce. Of the 200 sanctioned posts, only 82 drug inspectors (DIs) are presently active, prompting a concentrated effort to bolster manpower particularly in the Marathwada and Vidarbha regions, currently grappling with a pronounced shortage.
Additionally, the regulatory body faces a substantial shortage of Assistant Commissioners (ACs), with 38 out of the 66 sanctioned posts vacant. In terms of manufacturing units, Maharashtra today has 940 allopathic, 466 ayurvedic, 24 homoeopathic, and 395 cosmetics manufacturing units. Furthermore, the state boasts 57 public testing labs distributed strategically across its regions.
What have been the measures undertaken towards blood safety?
In a significant leap forward for healthcare infrastructure in the state, the Maharashtra FDA has recently granted licenses to 23 more blood banks, amounting to a total of 366 blood banks within the past three years.
The Maharashtra FDA’s focus on expanding blood bank infrastructure in the state aligns with the Union health ministry's mandate of fostering voluntary blood donation. The state drug regulator has registered a positive growth of 10 per cent in blood banks, indicating a robust upward trend.
The diverse landscape of blood banks in Maharashtra now comprises 279 trust-operated, 77 civic-run, and 10 private establishments, enhancing accessibility and coverage for different sectors of the population. This strategic expansion aims to meet the dynamic healthcare needs of the Maharashtra state.
India continues to grapple with an annual shortfall of approximately 10 lakh blood units in meeting its blood supply requirements. Mumbai, a key hub, faces a monthly demand for 30,000 blood units alone. In response to this ongoing challenge, healthcare giant Abbott has also initiated a nation-wide youth blood donation awareness campaign, contributing to the collective effort to bridge the supply-demand gap.
As of today, the e-Rakt Kosh platform, currently enforcing the Drugs and Cosmetics (D&C) Act along with National Blood Policy Standards and Guidelines, stands as a pivotal tool in the efficient management of the blood donation life cycle. With a biometric donor management system in place, the platform ensures proper identification, tracking, and screening of donors based on their health and donation history. Its comprehensive approach covers critical aspects such as blood grouping, transfusion transmitted infection (TTI) screening, antibody screening, and component preparation, adhering to defined processes and rules.
The platform extends its influence through a centralised blood inventory management system that facilitates real-time tracking of blood stocks across numerous blood banks. A robust biomedical waste management system ensures the proper disposal of discarded blood and related waste. Furthermore, e-Rakt Kosh actively contributes to the generation of rare blood group donor registries, encourages regular repeat donors, and employs an alert and notification system to enhance efficiency.
In line with an internal blood exchange policy, blood banks with surplus quantities are mandated to share their excess blood stock with counterparts facing relative shortages. This collaborative approach optimally regulates blood distribution throughout the city of Mumbai.
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