Directive No. 20-BYT/CT on improving the quality of medicines produced and circulated at units and localities.

DIRECTIVE
OF THE MINISTRY OF HEALTH NO. 20-BYT/CT ON JULY 18, 1985 REGARDING IMPROVEMENT
OF THE QUALITY OF MEDICINES PRODUCED AND
DISTRIBUTED AT VARIOUS UNITS AND LOCALITIES

In recent years, implementing the viewpoints of the Party on health work, the policies of the State and the sector, pharmaceutical work has made significant progress:

The pharmaceutical industry has been established and developed at central and local levels, (currently there are 11 central enterprises, 9 pharmaceuticals, 2 chemical drugs, 1 packaging) and 46 provincial and municipal enterprises with a volume including 200 million tubes (mostly oral tubes), 2 billion tablets (a significant portion from medicinal herbs), 800 tons of granules and pills, 3 million liters of liquid medicine and medicinal alcohol... with a value of 170 million dong in 1983, contributing significantly to the source of medicines for disease prevention and treatment needs. Attention has been paid to replacing some imported raw materials and exporting certain medicines (importantly ointments and liniments). Some valuable medicines have gained trust from doctors and the public (diarrhea, dysentery and intestinal diseases, anti-ulcer drugs for stomach and duodenum; antipyretic and cold remedies suitable for dengue fever; anti-rheumatic drugs; sedatives; diuretics; tonics, etc.). The quality of some medicines has improved, and standards of some medicines have gradually increased. There have been many improvements in production management, technical management, and quality control.

However, pharmaceutical production also reveals many shortcomings: The product structure is not reasonable, medicinal alcohol accounts for a high proportion, nutritional and general tonic medicines are abundant, the quality of many medicines is still unstable, presentation and packaging are not sufficiently attractive.

Management work also has shortcomings:

The production process is not stable, so after a period of production, quality decreases (especially antibiotics).

Insufficient conditions regarding personnel and equipment to check quality during production (many localities produce antibiotics, corticosteroids, vitamins... but cannot test them).

Production management is decentralized, unable to firmly grasp the quality of medicines produced in batches.

Producing medicines from imported raw materials in many enterprises without meeting the required conditions and without reporting for permission.

Many products circulating in various regions have not obtained permits from the Ministry, many Health Departments cannot manage the products manufactured and circulated within their localities.

To implement Resolution No. 6 and No. 8 of the Central Committee of the Party on eliminating bureaucratic and supply-based practices and fully transitioning to socialist business accounting while fulfilling the main political tasks of the Pharmaceutical Sector, which is to address the issue of medicines for disease treatment and overcome the scattered, fragmented, and parochial situation, building and improving material and technical facilities for large-scale production, ensuring the effectiveness of disease prevention and treatment through medicines, and achieving the highest economic efficiency according to the direction of concentration and specialization.

The Ministry requests units and localities to review the medicines currently being produced and circulated to reform the product structure and improve quality based on the following principles: 1. Ensuring efficacy (standard technical formula - technical procedures and necessary clinical research files).

2. Ensuring production conditions (material and technical infrastructure commensurate with the products being produced).

3. A team of staff and technical equipment to strictly manage quality during production.

4. Organizing production management - technical management - quality management.

Specifically:

a) Re-examine the products being produced:

- Medicines that can be planned for long-term production;

- Raw materials for medicines (alcoholic extracts, chemicals);

- Treatment medicines;

- Specialties or medicines with strengths of the unit or locality.

Meeting:

- Disease prevention and treatment efficacy confirmed;

- Stable production technology;

- Stable quality demonstrated:

Having technical standards and upgraded after two years of circulation;

Being distinctive and distinguishable from counterfeits;

At least 12-18 months shelf life;

Appealing presentation and packaging generating confidence.

- Types to reduce or eliminate from 1986 to 1990;

- Medicinal alcohols and general tonics with little or no effect.

- Medicines mixed with food.

- Medicines without clinical summary and evaluation.

- Medicines changing formulas and compositions reducing or losing effects.

- Medicines without conditions for quality testing and evaluation.

- Medicines mixed with food.

- Medicines with quality issues.

- Medicines in stock.

b) Based on the conditions of infrastructure, equipment, personnel, quality testing conditions, and organizational management, determine the products and classify them according to the level; Produce at provincial pharmaceutical factories; produce at hospitals and pharmacies; produce at district and commune levels.

c) Long-term production planning of units and localities should focus on what issues to leverage strengths and create products for nationwide supply.

d) Planning the construction of factories concerning:

- Infrastructure

- Technical equipment

- Staff team

- Technical and quality management organization.

Implementation plan.

1. For medicines produced by central units and local enterprises (circulating nationwide or approved by the Ministry and not under the jurisdiction of the Department's approval) will be reviewed and reported by central units and local Health Departments to the Ministry for inclusion in the unified national drug directory.

Other medicines produced by local enterprises will be reviewed and reported by the enterprises to the Departments for inclusion in the local drug directory.

2. After reviewing, prepare a report including the following contents:

- Drug name

- Formula composition when first approved for production, actual production

- Permit number

- Quantity produced in the years 1981-1985.

- Technical standard level? Applied from? Revised and upgraded from... achieved criteria - unachieved criteria.

- Efficacy in disease prevention and treatment (compare production quantity, doctor opinions, user feedback, etc.).

- Recommendation to retain, eliminate, reduce from what time?

- Production plan 1986-1990 (recommendation).

- Production Plan 1986-1990 (for consideration).

3. Local units shall appoint some officials who are well-versed in the issue to prepare opinions for review by the Scientific and Technical Council or the Drug Review Council to re-examine the list of drugs produced and circulated in their localities - The meetings for re-examination must assign a secretary to record all discussed opinions, issues agreed upon, not yet agreed upon, and recommendations.

At the Ministry, the Department of Drugs shall prepare to re-examine the entire list of drugs produced and circulated nationwide through the Pharmacology Council and submit the List of Drugs Produced and Circulated from 1986 to 1990, along with the classification of production items according to levels.

4. The above issues will be carried out within three months, July-August-September 1985, and local units shall report back to the Ministry from August 31 to September 15, 1985.

5. The Ministry requires local units to immediately cease the production and circulation of drugs that have not been reviewed and granted permits as prescribed. The deadline for completing this task is at most until September 30, 1985. After September 30, 1985, any local unit that continues to produce and circulate drugs without permits shall bear responsibility for violating principles.

6. The Ministry assigns the Department of Drugs the responsibility to guide, inspect, and urge the implementation of this Directive throughout the country.